Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT01675050
Status:
TERMINATED
Last Update Posted:
2017-08-30
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ismaeel.hashemi@gmail.com', 'phone': '6169165566', 'title': 'Ismaeel Hashemi, M.D. Principal Investigator', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Statistical analyses were not conducted due to small sample size. Results should be interpreted with extreme caution.'}}, 'adverseEventsModule': {'timeFrame': '10 weeks during study', 'eventGroups': [{'id': 'EG000', 'title': 'Cyproheptadine', 'description': 'All participants while on Cyproheptadine.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'All participants while on Placebo.', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increase Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence (Drowsiness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restless Sleeping Pattern', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble Sleeping (Insomnia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pressure Pain Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Post Cyproheptadine'}, {'id': 'OG001', 'title': 'All Participants Post Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '.73', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 4 weeks of cyproheptadine or placebo treatment', 'description': "Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.", 'unitOfMeasure': 'kg/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Post Cyproheptadine'}, {'id': 'OG001', 'title': 'All Participants Post Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5.25', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '8', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyproheptadine First, Then Placebo', 'description': '4 weeks of cyproheptadine with crossover to 4 weeks of placebo.'}, {'id': 'FG001', 'title': 'Sugar Pill First, Than Cyproheptadine', 'description': '4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine'}], 'periods': [{'title': 'Period One Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash Out Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Period Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyproheptadine Then Placebo', 'description': '4 weeks of cyproheptadine with crossover to 4 weeks of placebo.'}, {'id': 'BG001', 'title': 'Placebo Then Cyproheptadine', 'description': '4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '16'}, {'value': '10.5', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '12'}, {'value': '11.5', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pressure Pain Threshold', 'classes': [{'title': 'Baseline prior to First Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.75', 'spread': '2', 'groupId': 'BG000'}, {'value': '1.28', 'spread': '.53', 'groupId': 'BG001'}, {'value': '1.51', 'spread': '.99', 'groupId': 'BG002'}]}]}, {'title': 'Baseline prior to Second Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0', 'groupId': 'BG000'}, {'value': '1.08', 'spread': '.18', 'groupId': 'BG001'}, {'value': '1.13', 'spread': '.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Increasing pressures are applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in in kilograms divided by centimeters squared.", 'unitOfMeasure': 'kg/cm^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.'}, {'title': 'Improvement in Abdominal Pain', 'classes': [{'title': 'Baseline prior to First Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'spread': '5.66', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '2.12', 'groupId': 'BG001'}, {'value': '6.25', 'spread': '4.35', 'groupId': 'BG002'}]}]}, {'title': 'Baseline prior to Second Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '3.45', 'groupId': 'BG001'}, {'value': '6.33', 'spread': '2.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This is a pain scale derived from the abdominal pain Index child version, where on a scale of zero to 10, zero represents no pain, and ten represents the most pain possible', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline."}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Due to the wide availability of the drug in clinical practice, it was impossible to recruit adequate numbers for scientific power.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2012-08-27', 'resultsFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-26', 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Pain Threshold', 'timeFrame': 'at 4 weeks of cyproheptadine or placebo treatment', 'description': "Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared."}], 'secondaryOutcomes': [{'measure': 'Abdominal Pain', 'timeFrame': '10 weeks', 'description': 'Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Functional Abdominal Pain']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 8 and 18 years-old\n* Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all\\* of the following:\n\n 1. Episodic or continuous abdominal pain\n 2. Insufficient criteria for other FGIDs\n 3. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms\n\n * Criteria fulfilled at least once per week for at least 2 months prior to diagnosis\n* Written informed consent obtained from the patient/guardian before the initiation of any study-specific procedures\n\nExclusion Criteria:\n\n* Age \\< 8 years-old or Age \\>18 years-old\n* Child or parent are non-English speakers\n* Child is using other CNS depressants (cyproheptadine causes drowsiness, and may enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates, Droperidol, Hydroxyzine, Alcohol)(29)\n* Child has a history of hypersensitivity to Cyproheptadine products\n* Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan, Parnate) (can cause a prolonged or intensified anticholinergic effect)\n* Child was treated with Cyproheptadine in the past 4 weeks\n* Child is currently using anticholinergic (can cause an additive anticholinergic effect e.g. Pramlintide)\n* Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)\n* Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine\n* Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice versa.\n* Child has a personal history of glaucoma\n* Child has asthma (can cause thickening of bronchial secretions) (27,28)\n* History of liver dysfunction/disease (can cause hepatitis)\n* History of cardiac disease (not specific to Cyproheptadine, antihistamines have been associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).\n* Females who are known to be pregnant will also be excluded. All females who are of child bearing age, or are already menstruating will perform a urine pregnancy test before enrolling.\n* Any children who have difficulties swallowing tablets will receive teaching on how to swallow tablets. If they are still unable to do so, they will not participate in the study."}, 'identificationModule': {'nctId': 'NCT01675050', 'briefTitle': 'A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain', 'orgStudyIdInfo': {'id': 'HUM00056045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyproheptadine first then Placebo', 'description': '4 weeks of cyproheptadine or placebo with crossover to the other', 'interventionNames': ['Drug: Cyproheptadine', 'Drug: sugar pill']}, {'type': 'EXPERIMENTAL', 'label': 'Sugar Pill first then Cyprotheptadine', 'description': '4 weeks of cyproheptadine or placebo with crossover to the other', 'interventionNames': ['Drug: Cyproheptadine', 'Drug: sugar pill']}], 'interventions': [{'name': 'Cyproheptadine', 'type': 'DRUG', 'otherNames': ['Periactin'], 'description': '4 weeks of cyproheptadine or placebo with crossover to the other', 'armGroupLabels': ['Cyproheptadine first then Placebo', 'Sugar Pill first then Cyprotheptadine']}, {'name': 'sugar pill', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': '4 weeks of cyproheptadine or placebo with crossover to the other', 'armGroupLabels': ['Cyproheptadine first then Placebo', 'Sugar Pill first then Cyprotheptadine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'UmichiganHS', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Ismaeel Hashemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow Physician', 'investigatorFullName': 'Ismaeel Hashemi', 'investigatorAffiliation': 'University of Michigan'}}}}