Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT04095104
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2019-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010645', 'term': 'Phentermine'}, {'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaime.moore@cuanschutz.edu', 'phone': '303-724-8419', 'title': 'Jaime Moore, MD MPH', 'organization': 'University of Colorado School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data for the entire trial were collected from the first study activity of the first participant through the final study activity of the last participant, which was from: 2/10/20 through 1/25/22. In general, for each participant, adverse event screening lasted from the enrollment visit through the final study phone call (~4 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed mood', 'notes': 'subjectively reported as different from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'notes': 'subjectively reported - above baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty with concentration/attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in Taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstruation change', 'notes': 'Among participants with biological sex of female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental fogginess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Word finding difficulties', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back, side, and/or groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal fullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Finger fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inability to cool down', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling in arms, legs, face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal pain', 'notes': 'Among female participants (mentioned under "any other adverse event experienced")', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression Score by CES-D that increased from normal to elevated (>=20) on study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality screen (CSSRS) positivity on study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low bicarbonate (<20mmol/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low potassium (<3.5mmol/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated creatinine', 'notes': 'above upper limit of normal mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Positive urine pregnancy test', 'notes': 'Among female participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated systolic blood pressure (>=120mmHg)', 'notes': 'at any visit while on study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated diastolic BP (>=80mmHg)', 'notes': 'at any visit while on study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated heart rate (>=100 beats per minute)', 'notes': 'at any visit while on study treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated temperature (measured)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospital admission', 'notes': 'Severe back pain, which after inpatient diagnostic evaluation was deemed not to be related to study intervention. Specifically, no evidence of nephrolithiasis was found.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants Before Randomization', 'description': 'The enrollment rate was calculated before randomization to active or placebo groups.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '(Number enrolled divided by number eligible) x 100', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dropout Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets that were compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Number who do not complete the study divided by number enrolled', 'unitOfMeasure': 'percentage who withdrew among enrolled', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Adherent to Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Presence of amphetamine in the urine at any study visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.'}, {'type': 'PRIMARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '27'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.', 'unitOfMeasure': 'unique adverse events per participant', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent BMI Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.61', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '2.86'}, {'value': '1.89', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '4.62'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.72', 'groupId': 'OG000', 'lowerLimit': '-12.14', 'upperLimit': '2.61'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '-6.94', 'upperLimit': '6.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline weight - weight at 12 weeks)/Baseline weight x 100', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BMI Percent of the 95th%Ile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)', 'unitOfMeasure': 'percentile change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was \\<95th%ile or they were \\>19 completed years at the time point.'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'groupId': 'OG000', 'lowerLimit': '-16.67', 'upperLimit': '47.33'}, {'value': '-0.83', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '6.33'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Heart rate at baseline - Heart rate at 12 weeks)', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '23'}, {'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '-6.67', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '11.67'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '-6.67', 'upperLimit': '20.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18', 'groupId': 'OG000', 'lowerLimit': '-47', 'upperLimit': '33'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Total cholesterol at baseline - Total cholesterol at 12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.17', 'groupId': 'OG000', 'lowerLimit': '-42', 'upperLimit': '55'}, {'value': '-6.33', 'groupId': 'OG001', 'lowerLimit': '-71', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Triglycerides at baseline - Triglycerides at 12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LDL Cholesterol (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.73', 'groupId': 'OG000', 'lowerLimit': '-39', 'upperLimit': '26.2'}, {'value': '7.43', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '21.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'LDL at baseline - LDL at 12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.83', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '3'}, {'value': '-0.17', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HDL at baseline - HDL at 12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT) (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '16'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'ALT at baseline - ALT at 12 weeks', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin A1c (HbA1c) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.7'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HbA1c at baseline - HbA1c at 12 weeks', 'unitOfMeasure': 'Percentage of glycated hemoglobin', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in % Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '1.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA', 'unitOfMeasure': 'percentage of fat mass', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Resting Metabolic Rate (RMR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-97.8', 'groupId': 'OG000', 'lowerLimit': '-249.2', 'upperLimit': '87'}, {'value': '-32.1', 'groupId': 'OG001', 'lowerLimit': '-110.5', 'upperLimit': '44.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'RMR at baseline - RMR at 12 weeks measured by indirect calorimetry', 'unitOfMeasure': 'kilocalories per day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Daily Kilocalorie Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-339.32', 'groupId': 'OG000', 'lowerLimit': '-1409.39', 'upperLimit': '412.08'}, {'value': '94.85', 'groupId': 'OG001', 'lowerLimit': '-266.99', 'upperLimit': '719.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.', 'unitOfMeasure': 'kilocalories', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hunger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.76', 'groupId': 'OG000', 'lowerLimit': '-36', 'upperLimit': '11'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '-39', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'VAS hunger ratings were missing from 1 participant in each the active and placebo groups'}, {'type': 'SECONDARY', 'title': 'Change in Satiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '33'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'VAS missing from 1 participant each in the active and placebo groups'}, {'type': 'SECONDARY', 'title': 'Change in Eating in the Absence of Hunger', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'groupId': 'OG000', 'lowerLimit': '-23', 'upperLimit': '0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.\n\nEach item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.\n\nTotal scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.\n\nThe mean change in total scores by group are presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Restraint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.83', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '5'}, {'value': '-0.33', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.\n\nThe cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.\n\nMINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'groupId': 'OG000', 'lowerLimit': '-6.48', 'upperLimit': '7.41'}, {'value': '3.61', 'groupId': 'OG001', 'lowerLimit': '-8.33', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age \\<=19.\n\nTotal and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.\n\nHigher scores indicate higher quality of life.', 'unitOfMeasure': 'units on a transformed scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.94', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '12.96'}, {'value': '-0.62', 'groupId': 'OG001', 'lowerLimit': '-15.74', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': '"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.\n\nTotal and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.\n\nHigher scores indicate higher quality of life.', 'unitOfMeasure': 'units on a transformed scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.67', 'groupId': 'OG000', 'lowerLimit': '-18', 'upperLimit': '7'}, {'value': '3.17', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.\n\nItems are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.\n\nScale Scores are calculated as the sum of the items over the number of items answered.\n\nHigher scores indicated better health-related quality of life.', 'unitOfMeasure': 'units on a transformed scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '15'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).\n\nEach item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction: Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets compounded to look like phentermine and topiramate plus standard post-bariatric care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5'}, {'value': '4.75', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12 weeks', 'description': 'The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.\n\nThe outcome presented here is the average of the parent and adolescent/young adult dyad\'s response to the statement: "My overall experience was positive" \\[1=Strongly disagree, 5=Strongly agree\\]', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.\n\nDosing schedule for active medication group:\n\n* Week 1: 4mg phentermine + 25mg immediate release topiramate\n* Week 2: 8mg phentermine + 50mg immediate release topiramate\n* Week 3: 12mg phentermine + 75mg immediate release topiramate\n\nGoal Dose:\n\n· Weeks 4-12: 16mg phentermine + 100mg immediate release topiramate\n\nDiscontinuation (at study Visit 4):\n\n* Week 13: Discontinue Phentermine + Decrease topiramate to 50mg\n* Week 14: Decrease topiramate to 25mg for 7 days, then discontinue\n\nNotes:\n\n1. Participants who do not tolerate goal doses will be maintained at the highest tolerated dose.\n2. All topiramate and phentermine doses will be taken once daily in the morning.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets that were compounded to look identical to phentermine and topiramate plus standard post-bariatric care.\n\nDosing escalation, goal dose, and discontinuation for placebo group was identical to the active group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'comment': '1 participant randomized to the placebo group withdrew before taking a single dose of study medication due to family psychosocial stressors unrelated to this study.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phentermine & Topiramate', 'description': 'Participants were randomized to receive phentermine and topiramate plus standard post-bariatric care.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo tablets (compounded to look like phentermine and topiramate) plus standard post-bariatric care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '20'}, {'value': '17.9', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '17.3', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-21', 'size': 521247, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-26T19:00', 'hasProtocol': True}, {'date': '2021-07-30', 'size': 270035, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-26T19:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'At baseline, each participant will be randomized 1:1 to either 12 weeks of phentermine, topiramate and standard of care or 12 weeks of phentermine placebo, topiramate placebo, and standard of care. This randomization will be blinded to the participant, investigator, care providers, and outcomes assessor for the duration of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel assignment where the experimental arm will receive active drugs + standard of care and the control arm will receive placebo drugs + standard of care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2019-09-17', 'resultsFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-07', 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment Rate', 'timeFrame': '6 months', 'description': '(Number enrolled divided by number eligible) x 100'}, {'measure': 'Dropout Rate', 'timeFrame': '24 months', 'description': 'Number who do not complete the study divided by number enrolled'}, {'measure': 'Number of Participants Adherent to Study Drugs', 'timeFrame': '12 weeks', 'description': 'Presence of amphetamine in the urine at any study visit'}, {'measure': 'Frequency of Adverse Events', 'timeFrame': '24 months', 'description': 'Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.'}], 'secondaryOutcomes': [{'measure': 'Percent BMI Change', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100'}, {'measure': 'Percent Weight Change', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline weight - weight at 12 weeks)/Baseline weight x 100'}, {'measure': 'Change in BMI Percent of the 95th%Ile', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Baseline and 12 weeks', 'description': '(Heart rate at baseline - Heart rate at 12 weeks)'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks'}, {'measure': 'Change in Total Cholesterol (mg/dL)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Total cholesterol at baseline - Total cholesterol at 12 weeks'}, {'measure': 'Change in Triglycerides (mg/dL)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Triglycerides at baseline - Triglycerides at 12 weeks'}, {'measure': 'Change in LDL Cholesterol (mg/dL)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'LDL at baseline - LDL at 12 weeks'}, {'measure': 'Change in HDL Cholesterol (mg/dL)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HDL at baseline - HDL at 12 weeks'}, {'measure': 'Change in Alanine Aminotransferase (ALT) (U/L)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'ALT at baseline - ALT at 12 weeks'}, {'measure': 'Change in Hemoglobin A1c (HbA1c) (%)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'HbA1c at baseline - HbA1c at 12 weeks'}, {'measure': 'Change in % Fat Mass', 'timeFrame': 'Baseline and 12 weeks', 'description': '% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA'}, {'measure': 'Change in Resting Metabolic Rate (RMR)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'RMR at baseline - RMR at 12 weeks measured by indirect calorimetry'}, {'measure': 'Change in Daily Kilocalorie Intake', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.'}, {'measure': 'Change in Hunger', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.'}, {'measure': 'Change in Satiety', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.'}, {'measure': 'Change in Eating in the Absence of Hunger', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.\n\nEach item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.\n\nTotal scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.\n\nThe mean change in total scores by group are presented.'}, {'measure': 'Change in Cognitive Restraint', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.\n\nThe cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.\n\nMINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)'}, {'measure': 'Change in Total Weight Related Quality of Life- Adolescent/Young Adult Report', 'timeFrame': 'Baseline and 12 weeks', 'description': '"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age \\<=19.\n\nTotal and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.\n\nHigher scores indicate higher quality of life.'}, {'measure': 'Change in Total Weight Related Quality of Life- Parent Reported of Adolescent/Young Adult', 'timeFrame': 'Baseline and 12 weeks', 'description': '"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.\n\nTotal and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.\n\nHigher scores indicate higher quality of life.'}, {'measure': 'Change in General Health Related Quality of Life: Total Score PedsQL Instrument - Self Report', 'timeFrame': 'Baseline and 12 weeks', 'description': 'PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.\n\nItems are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.\n\nScale Scores are calculated as the sum of the items over the number of items answered.\n\nHigher scores indicated better health-related quality of life.'}, {'measure': 'Change in Depression', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).\n\nEach item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.'}, {'measure': 'Participant Satisfaction: Questionnaire', 'timeFrame': 'At 12 weeks', 'description': 'The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.\n\nThe outcome presented here is the average of the parent and adolescent/young adult dyad\'s response to the statement: "My overall experience was positive" \\[1=Strongly disagree, 5=Strongly agree\\]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilot', 'Feasibility', 'Initial Efficacy', 'Randomized Controlled Trial'], 'conditions': ['Obesity, Morbid', 'Bariatric Surgery', 'Adolescent', 'Young Adult', 'Drug Therapy']}, 'descriptionModule': {'briefSummary': "The goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. This study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Status post sleeve gastrectomy or roux-en-y gastric bypass\n* At 6 months after bariatric surgery, has not achieved \\>= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (\\>=120% of 95th%ile or BMI \\>=35kg/m2 for 12-17yo; BMI \\>=35kg/m2 for 18-24yo)\n\nExclusion Criteria:\n\n* Absolute contraindication to phentermine or topiramate (i.e. phentermine:\n\nhistory of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)\n\n* Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)\n* Use of anti-obesity medication within 6 months of screening\n* Initiation of a new medication associated with weight loss or gain within 30 days of screening\n* Type 2 diabetes mellitus\n* Hypothalamic obesity\n* Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety\n* History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening\n* History of schizophrenia\n* Severe hepatic impairment (ALT \\>10x upper limit of normal or known synthetic liver dysfunction)\n* Moderate or severe renal impairment (GFR \\<30mL/min/1.73m2)\n* Dosage change to hypertension, dyslipidemia, depression, or anxiety medication \\<4 weeks prior to study enrollment\n* Contraception started \\<7 days prior to study enrollment\n* Current pregnancy/plans to become pregnant within 16 weeks from study drug start date\n* Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control'}, 'identificationModule': {'nctId': 'NCT04095104', 'briefTitle': 'Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Adjunctive Anti-Obesity Pharmacotherapy in Adolescents and Young Adults After Bariatric Surgery: A Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': '18-2793'}, 'secondaryIdInfos': [{'id': '5P30DK048520-24', 'link': 'https://reporter.nih.gov/quickSearch/5P30DK048520-24', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phentermine & Topiramate', 'description': 'Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration:\n\n4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning\n\n\\+\n\nImmediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning\n\n\\+\n\nStandard of Care (multidisciplinary postoperative bariatric surgery clinic visits)', 'interventionNames': ['Drug: Phentermine', 'Drug: Immediate Release Topiramate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Drugs', 'description': 'Placebo Phentermine- Formulation: 8mg scored tablet, Dosage/Frequency/Duration: 4mg x 7d then 8mg x 7d then 12mg x 7d then 16mg x 63d, taken once every morning\n\n\\+\n\nPlacebo Immediate release topiramate- Formulation: 25mg tablet, Dosage/Frequency/Duration: 25mg x 7d then 50mg x 7d then 75mg x 7d then 100mg x 63d then 50mg x 7 days then 25mg x 7d, taken once every morning\n\n\\+\n\nStandard of Care (multidisciplinary postoperative bariatric surgery clinic visits)', 'interventionNames': ['Drug: Placebo for Phentermine', 'Drug: Placebo for Immediate Release Topiramate']}], 'interventions': [{'name': 'Phentermine', 'type': 'DRUG', 'otherNames': ['Lomaira', 'Adipex-P', 'C045TQL4WP', '2-methyl-1-phenylpropan-2-amine'], 'description': 'Phentermine tablet', 'armGroupLabels': ['Phentermine & Topiramate']}, {'name': 'Immediate Release Topiramate', 'type': 'DRUG', 'otherNames': ['Topamax', '0H73WJJ391', "[(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate"], 'description': 'Topiramate tablet', 'armGroupLabels': ['Phentermine & Topiramate']}, {'name': 'Placebo for Phentermine', 'type': 'DRUG', 'description': 'Compounded tablet to mimic phentermine 8mg tablet', 'armGroupLabels': ['Placebo Drugs']}, {'name': 'Placebo for Immediate Release Topiramate', 'type': 'DRUG', 'description': 'Compounded tablet to mimic immediate release topiramate 25mg tablet', 'armGroupLabels': ['Placebo Drugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jaime M Moore, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest in obesity. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'University of Colorado- Clinical and Translational Sciences Institute', 'class': 'UNKNOWN'}, {'name': 'University of Colorado- Nutrition Obesity Research Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}