Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT01887002
Status:
TERMINATED
Last Update Posted:
2016-02-25
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607300', 'term': 'ONO-2952'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'The study was terminated due to slow accrual of subjects.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2016-01-26', 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2013-06-24', 'dispFirstSubmitQcDate': '2016-01-26', 'studyFirstSubmitQcDate': '2013-06-25', 'dispFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity rating during rectal distention by using a numeric pain rating scale', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety assessed through adverse events and clinical laboratory values', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Irritable Bowel Syndrome', 'IBS', 'ONO-2952'], 'conditions': ['Irritable Bowel Syndrome (IBS)']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female 18-65 years of age (inclusive)\n2. Diagnosed with IBS based on the following criteria (Rome III criteria):\n\n * Symptom onset at least 6 months prior to diagnosis, and\n * Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and\n * Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:\n * improvement with defecation\n * onset associated with a change in frequency of stool/defecation\n * onset associated with a change in form (appearance) of stool\n3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations\n\nExclusion Criteria:\n\n* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)\n* History of Chron's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms"}, 'identificationModule': {'nctId': 'NCT01887002', 'acronym': 'RESTORE', 'briefTitle': 'Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effects of ONO-2952 on Pain Perception Produced by Rectal Distention in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (RESTORE)', 'orgStudyIdInfo': {'id': 'ONO-2952POU005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm 1', 'description': 'ONO-2952 Active tablets, every day for 2 weeks', 'interventionNames': ['Drug: ONO-2952']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'ONO-2952 Matching Placebo every day for 2 weeks', 'interventionNames': ['Drug: Placebo comparator']}], 'interventions': [{'name': 'ONO-2952', 'type': 'DRUG', 'description': 'ONO-2952 Active tablets, every day for 2 weeks', 'armGroupLabels': ['Experimental Arm 1']}, {'name': 'Placebo comparator', 'type': 'DRUG', 'description': 'ONO-2952 Matching Placebo every day for 2 weeks', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Clinical Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Chapel Hill Clinical Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '73160', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma City Clinical Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Ono Pharma USA, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharma USA Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}