Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-04-24 @ 1:47 PM
Study NCT ID:
NCT03012594
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lanreotide in the Treatment of Small Bowel Motility Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060347', 'term': 'lanreotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmiller7@northwell.edu', 'phone': '5165620334', 'title': 'Dr.Larry Miller', 'organization': 'Northwell health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This is a pilot non-randomized study in relatively small number of subjects to identify if Lanreotide will help in alleviating the symptoms and and change gut motility in patients suffering from small bowel motility disorders. A larger study randomized study is required to confirm the findings in this study.'}}, 'adverseEventsModule': {'timeFrame': '1 month after last dose, up to 4 months from the start for each subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Lanreotide', 'description': 'Open label\n\nLanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Difficulty swallowing wireless motility capsule pill', 'notes': 'One patient had difficulty in swallowing the wireless motility capsule and had a sensation that it was struck in the throat. Upon additional examination the subject was fine and was sent home.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unable to acknowledge the passage of the wireless motility capsule through the feces', 'notes': 'Subject was not able to acknowledge the passage of the wireless motility capsule through the feces after the end of 4 days after ingestion. An abdominal x-ray was performed to confirm that the capsule was indeed expelled.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanreotide', 'description': 'Open label\n\nLanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart'}], 'classes': [{'title': 'Gastric emptying time', 'categories': [{'measurements': [{'value': '371.52', 'spread': '45.18', 'groupId': 'OG000'}]}]}, {'title': 'Small bowel transit time', 'categories': [{'measurements': [{'value': '392', 'spread': '47.51', 'groupId': 'OG000'}]}]}, {'title': 'Colonic transit time', 'categories': [{'measurements': [{'value': '4767', 'spread': '1286', 'groupId': 'OG000'}]}]}, {'title': 'Small bowel and Colonic transit time', 'categories': [{'measurements': [{'value': '5159', 'spread': '1284', 'groupId': 'OG000'}]}]}, {'title': 'Whole gut transit time', 'categories': [{'measurements': [{'value': '5530', 'spread': '1322', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to \\< 6hrs, then patient would be considered a responder and that lanreotide is efficacious.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanreotide', 'description': 'Open label\n\nLanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart'}], 'classes': [{'title': 'Heartburn/regurgitation', 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Nausea/vomiting', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Fullness/early satiety', 'categories': [{'measurements': [{'value': '2.36', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Bloating', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.47', 'groupId': 'OG000'}]}]}, {'title': 'Upper abdominal pain', 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Lower abdominal pain', 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.\n\nThe participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nPAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lanreotide', 'description': 'Open label\n\nLanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'First subject was enrolled on 5/11/2017 and the last subject was enrolled on 7/19/2018. All study visits were performed either at a medical clinic or gastroenterology unit. There were also phone follow-ups.', 'preAssignmentDetails': 'This is an open label non-randomized study. All enrolled participants were checked to see if they meet all the screening requirements to participate. All willing and qualified participants received the study mediation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lanreotide', 'description': 'Open label\n\nLanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.78', 'spread': '13.33', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.11', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '70.67', 'spread': '10.91', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/sec', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Glucose', 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Heartburn/regurgitation', 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'spread': '1.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 7 symptoms -\n\n1. Heartburn during day\n2. Regurgitation during day\n3. Heartburn when lying\n4. Regurgitation when lying\n5. Chest discomfort during day\n6. Bitter taste in mouth\n7. Chest discomfort at night\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Nausea/vomiting', 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '2.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 3 symptoms -\n\n1. Nausea\n2. Retching\n3. Vomiting\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Fullness/early satiety', 'classes': [{'categories': [{'measurements': [{'value': '3.22', 'spread': '1.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 4 symptoms -\n\n1. Stomach fullness\n2. Loss of appetite\n3. Not able to finish meal\n4. Excessively full after meal\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Bloating', 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '1.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 2 symptoms -\n\n1. Bloating\n2. Stomach visibly larger\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Upper abdominal pain', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 2 symptoms -\n\n1. Upper abdominal pain\n2. Upper abdominal discomfort\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index_Lower abdominal pain', 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '1.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The participant rated each of the measured gastrointestinal symptom severity as described below. (Minimum of 0 and a Maximum of 5.) 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nThis subscale accessed the following 2 symptoms -\n\n1. Lower abdominal pain\n2. Lower abdominal discomfort\n\nThe computed score is an average of all these gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastric emptying time', 'classes': [{'categories': [{'measurements': [{'value': '323', 'spread': '232', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small bowel transit time', 'classes': [{'categories': [{'measurements': [{'value': '505', 'spread': '159', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colonic transit time', 'classes': [{'categories': [{'measurements': [{'value': '2503', 'spread': '1592', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small bowel and colonic transit time', 'classes': [{'categories': [{'measurements': [{'value': '2835', 'spread': '1556', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Whole gut transit time', 'classes': [{'categories': [{'measurements': [{'value': '3160', 'spread': '1533', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach Contractions', 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '1.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Contractions/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach Mean Pressure', 'classes': [{'categories': [{'measurements': [{'value': '4.44', 'spread': '3.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach High Pressure', 'classes': [{'categories': [{'measurements': [{'value': '313.82', 'spread': '53.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach Low pH', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '3.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach Median pH', 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '1.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stomach High pH', 'classes': [{'categories': [{'measurements': [{'value': '7.48', 'spread': '3.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastric Antrum Motility Index', 'classes': [{'categories': [{'measurements': [{'value': '17.68', 'spread': '22.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Gastric antrum is the wider part of the pylorus. It resides upstream from the pyloric canal and downstream from the stomach.\n\nGastric antral motility index = sum of amplitudes × number of contractions + 1.\n\nThe average motility index in normal subjects is approximately 11. Higher values indicate either increased contractions or increased amplitudes or both. Lower values indicate either decreased contractions or decreased amplitudes or both.', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum Contractions', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Contractions/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum Mean Pressure', 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '3.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum High Pressure', 'classes': [{'categories': [{'measurements': [{'value': '271.94', 'spread': '104.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum Low pH', 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum Median pH', 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antrum High pH', 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'spread': '1.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum Motility Index', 'classes': [{'categories': [{'measurements': [{'value': '16.84', 'spread': '22.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Duodenal motility index = sum of amplitudes × number of contractions + 1. Higher values indicate either increased contractions or increased amplitudes or both. Lower values indicate either decreased contractions or decreased amplitudes or both.', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum Contractions', 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '2.99', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Contractions/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum Mean Pressure', 'classes': [{'categories': [{'measurements': [{'value': '3.52', 'spread': '1.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum High Pressure', 'classes': [{'categories': [{'measurements': [{'value': '87.07', 'spread': '59.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum Low pH', 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum Median pH', 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'spread': '0.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duodenum High pH', 'classes': [{'categories': [{'measurements': [{'value': '7.07', 'spread': '0.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel Contractions', 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '2.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Contractions/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel Mean Pressure', 'classes': [{'categories': [{'measurements': [{'value': '4.03', 'spread': '1.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel High Pressure', 'classes': [{'categories': [{'measurements': [{'value': '143.67', 'spread': '88.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel Low pH', 'classes': [{'categories': [{'measurements': [{'value': '2.32', 'spread': '1.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel Median pH', 'classes': [{'categories': [{'measurements': [{'value': '7.36', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Small Bowel High pH', 'classes': [{'categories': [{'measurements': [{'value': '7.89', 'spread': '0.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon Contractions', 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'spread': '0.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Contractions/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon Mean Pressure', 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'spread': '1.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon High Pressure', 'classes': [{'categories': [{'measurements': [{'value': '177.84', 'spread': '108.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon Low pH', 'classes': [{'categories': [{'measurements': [{'value': '5.19', 'spread': '0.37', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon Median pH', 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'spread': '0.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Colon High pH', 'classes': [{'categories': [{'measurements': [{'value': '8.41', 'spread': '0.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-28', 'size': 583330, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-19T15:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2017-01-04', 'resultsFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-23', 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill', 'timeFrame': '3 months', 'description': 'If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to \\< 6hrs, then patient would be considered a responder and that lanreotide is efficacious.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"', 'timeFrame': '3 months', 'description': 'Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms.\n\nThe participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom.\n\nPAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small bowel motility disorder', 'Slow intestinal motility', 'Small bowel bacterial overgrowth'], 'conditions': ['Gastrointestinal Motility Disorder', 'Intestinal Disease']}, 'referencesModule': {'references': [{'pmid': '1944424', 'type': 'BACKGROUND', 'citation': 'Soudah HC, Hasler WL, Owyang C. Effect of octreotide on intestinal motility and bacterial overgrowth in scleroderma. N Engl J Med. 1991 Nov 21;325(21):1461-7. doi: 10.1056/NEJM199111213252102.'}, {'pmid': '8206395', 'type': 'BACKGROUND', 'citation': 'Owyang C. Octreotide in gastrointestinal motility disorders. Gut. 1994;35(3 Suppl):S11-4. doi: 10.1136/gut.35.3_suppl.s11.'}, {'pmid': '9692691', 'type': 'BACKGROUND', 'citation': 'Edmunds MC, Chen JD, Soykan I, Lin Z, McCallum RW. Effect of octreotide on gastric and small bowel motility in patients with gastroparesis. Aliment Pharmacol Ther. 1998 Feb;12(2):167-74. doi: 10.1046/j.1365-2036.1998.00289.x.'}, {'pmid': '10235603', 'type': 'BACKGROUND', 'citation': 'Faure C, Goulet O, Ategbo S, Breton A, Tounian P, Ginies JL, Roquelaure B, Despres C, Scaillon M, Maurage C, Paquot I, Hermier M, De Napoli S, Dabadie A, Huet F, Baudon JJ, Larchet M. Chronic intestinal pseudoobstruction syndrome: clinical analysis, outcome, and prognosis in 105 children. French-Speaking Group of Pediatric Gastroenterology. Dig Dis Sci. 1999 May;44(5):953-9. doi: 10.1023/a:1026656513463.'}, {'pmid': '17564625', 'type': 'BACKGROUND', 'citation': 'Stanghellini V, Cogliandro RF, de Giorgio R, Barbara G, Salvioli B, Corinaldesi R. Chronic intestinal pseudo-obstruction: manifestations, natural history and management. Neurogastroenterol Motil. 2007 Jun;19(6):440-52. doi: 10.1111/j.1365-2982.2007.00902.x.'}, {'pmid': '9414977', 'type': 'BACKGROUND', 'citation': 'Mann SD, Debinski HS, Kamm MA. Clinical characteristics of chronic idiopathic intestinal pseudo-obstruction in adults. Gut. 1997 Nov;41(5):675-81. doi: 10.1136/gut.41.5.675.'}, {'pmid': '24575015', 'type': 'BACKGROUND', 'citation': 'Lybaert W. The use of lanreotide autogel(R) in the treatment of intestinal obstruction in a patient with adenocarcinoma. Case Rep Oncol. 2014 Jan 16;7(1):43-6. doi: 10.1159/000358124. eCollection 2014 Jan.'}, {'pmid': '9056054', 'type': 'BACKGROUND', 'citation': 'Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.'}, {'pmid': '7991964', 'type': 'BACKGROUND', 'citation': 'Camilleri M. Small bowel motility disorders. Rev Gastroenterol Mex. 1994 Apr-Jun;59(2):120-6.'}, {'pmid': '21106692', 'type': 'BACKGROUND', 'citation': 'Wang C, Xu H, Chen H, Li J, Zhang B, Tang C, Ghishan FK. Somatostatin stimulates intestinal NHE8 expression via p38 MAPK pathway. Am J Physiol Cell Physiol. 2011 Feb;300(2):C375-82. doi: 10.1152/ajpcell.00421.2010. Epub 2010 Nov 24.'}, {'pmid': '20410227', 'type': 'BACKGROUND', 'citation': 'Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S; Acromegaly Consensus Group. A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab. 2010 Jul;95(7):3141-8. doi: 10.1210/jc.2009-2670. Epub 2010 Apr 21.'}, {'pmid': '20195905', 'type': 'BACKGROUND', 'citation': 'Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.'}, {'pmid': '15354277', 'type': 'BACKGROUND', 'citation': 'Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.'}, {'pmid': '15651544', 'type': 'BACKGROUND', 'citation': 'Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49. doi: 10.1007/s11136-004-9567-x.'}, {'pmid': '15479666', 'type': 'BACKGROUND', 'citation': 'De Giorgio R, Sarnelli G, Corinaldesi R, Stanghellini V. Advances in our understanding of the pathology of chronic intestinal pseudo-obstruction. Gut. 2004 Nov;53(11):1549-52. doi: 10.1136/gut.2004.043968.'}, {'pmid': '23831693', 'type': 'BACKGROUND', 'citation': 'Iida H, Ohkubo H, Inamori M, Nakajima A, Sato H. Epidemiology and clinical experience of chronic intestinal pseudo-obstruction in Japan: a nationwide epidemiologic survey. J Epidemiol. 2013;23(4):288-94. doi: 10.2188/jea.je20120173.'}, {'pmid': '16131977', 'type': 'BACKGROUND', 'citation': 'Goulet O, Sauvat F, Jan D. Surgery for pediatric patients with chronic intestinal pseudo-obstruction syndrome. J Pediatr Gastroenterol Nutr. 2005 Sep;41 Suppl 1:S66-8. doi: 10.1097/01.scs.0000180312.55417.8e. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a human research study looking at the effectiveness of Lanreotide (study medication) in treating small bowel motility disorders. It is similar to a natural hormone somatostatin that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting medication that is given once a month. It is marketed with a trade name "Somatuline Depot". It is given deep subcutaneously (deep within the layers of the skin) in the superior external quadrant of the buttock. Injection site will be alternated on subsequent injections.', 'detailedDescription': 'The investigators hypothesize that in patients with small bowel motility disorders, Lanreotide helps in alleviating the symptoms. Lanreotide is an FDA approved medication for management of acromegaly and neuroendocrine tumors, but has never been used for treating small bowel motility disorders. However, Octreotide which is similar to Lanreotide but is a short acting synthetic somatostatin has been used in few research studies.\n\nIf a patient is interested and qualifies for the study then he/she will be explained about the study and signature will be collected on the consent form. Health and social history will be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group and have the capability of getting pregnant)) will be performed to make sure that patient qualifies for the study and for follow-up during the treatment. Physical examination, ECG, wireless motility capsule testing and hydrogen breath testing will be performed. Patients will be required to complete a questionnaire regarding their health.\n\nThe total study duration from the first administration of study drug is 12 weeks. The study medication will be given once a month for 3 months and there is a 1 month follow-up after the last study medication. There will be a screening visit approximately 1 month before the first study drug administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Consecutive patients with evidence of small bowel motility disorders, referred to (or) are patients of the Gastroenterology and Motility Center at Northwell Health System.\n2. Aged between 18 and 70 years.\n3. Subjects should be capable of understanding the study and be able to give informed consent.\n4. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to \\> 6 hours.\n5. To participate in the study, patients will have to stop taking Octreotide (because it has the same mechanism of action as the study medication) if they are currently taking it; it should be stopped for at least 4 weeks before taking the first dose of this study medication.\n\nGeneral Exclusion Criteria\n\n1. Age \\<18 or age \\>70\n2. Pregnancy as assessed by urine pregnancy test.\n\nExclusion Criteria for performing wireless motility capsule testing\n\n1. History of gastric bezoar\n2. History of Disorders of swallowing\n3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse)\n4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y)\n5. History of Severe dysphagia to food or pills\n6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump\n7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.)\n8. Any person unable or unwilling to undergo abdominal surgery.\n9. BMI \\> 40.\n\nExclusion Criteria due to Lanreotide\n\n1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility.\n2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose \\> 250, glycosylated hemoglobin (HbA1c) \\> 8.5%)\n3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers.\n4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain).\n\n Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate.\n\n ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG.\n * Bradycardia \\<60 beats/min.\n * Tachycardia \\>100 beats/min.\n * Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and irregular ventricular rate.\n * Ventricular Fibrillation - Irregular ventricular waveforms.\n * Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60 to 100 beats per minute, causing varying R-R interval.\n * Missed beats.\n5. Chronic kidney disease (moderate and severe renal impairment as calculated by creatinine clearance of \\<50 mL/min)\n6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C.\n7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20 % will be considered as abnormal.\n8. Cholelithiasis (Total bilirubin \\>2x of normal)\n9. Pancreatitis\n10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin \\<3.0 g/dL unless prothrombin time is within the normal range)\n11. Present cholecystitis\n12. Uncontrolled congestive heart failure\n13. Known hypersensitivity to the study drug"}, 'identificationModule': {'nctId': 'NCT03012594', 'briefTitle': 'Lanreotide in the Treatment of Small Bowel Motility Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'A Pilot Study to Evaluate Safety and Effectiveness of Lanreotide in the Treatment of Patients With Small Bowel Motility Disorders (SBMD): a Prospective, Non-randomized, Single-center Study of 20 Participants', 'orgStudyIdInfo': {'id': 'HS16-0465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lanreotide', 'description': 'Open label', 'interventionNames': ['Drug: Lanreotide']}], 'interventions': [{'name': 'Lanreotide', 'type': 'DRUG', 'otherNames': ['Somatuline'], 'description': 'Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart', 'armGroupLabels': ['Lanreotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Larry Miller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Gastroenterology', 'investigatorFullName': 'Larry Miller', 'investigatorAffiliation': 'Northwell Health'}}}}