Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 11:11 PM
Study NCT ID:
NCT00215566
Status:
COMPLETED
Last Update Posted:
2007-05-28
First Post:
2005-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c
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': 'C527576', 'term': 'DDP733'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'lastUpdateSubmitDate': '2007-05-25', 'studyFirstSubmitDate': '2005-09-19', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effect of DDP733 on gastrointestinal transit'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the effect of DDP733 on patient reported outcomes'}]}, 'conditionsModule': {'keywords': ['IBS', 'IBS-c'], 'conditions': ['Irritable Bowel Syndrome With Constipation', 'Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria\n* Must have had endoscopic/radiologic bowel evaluation within the past 10 years\n* Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers\n* Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding\n\nExclusion Criteria:\n\n* Serious underlying diseases, including psychiatric disorders\n* Current history of conditions affecting bowel transit\n* Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection\n* Clinically significant abnormal examination findings or laboratory tests\n* Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments\n* Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome\n* Presence of a medical condition which could interfere with the interpretation of study data\n* Significant use of nicotine or caffeine'}, 'identificationModule': {'nctId': 'NCT00215566', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynogen Pharmaceuticals'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation', 'orgStudyIdInfo': {'id': 'DDP733-04-007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DDP733', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 4B9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Hys Medical Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'West Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.3286, 'lon': -123.16019}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QE II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Surrey GI Clinic', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Meadowlands Family Health Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Road Diagnostic Clinic', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sarnia Institute of Clinical Research', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'M3H 5S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Phase Onward Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M3N 2V7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Digestive Disease Associates, Inc', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1S 4L8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital St-Sacrement', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'William Paterson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hotel Dieu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dynogen Pharmaceuticals', 'class': 'INDUSTRY'}}}}