Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01296620
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2011-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ulimorelin Study of Efficacy and Safety (ULISES 008)
Sponsor:
Organization:
Raw JSON
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Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.'}]}, 'descriptionModule': {'briefSummary': 'Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women, 18 to 80 years of age, inclusive\n* Scheduled to undergo open bowel resection with colonic anastomosis\n* For women who can potentially become pregnant a pregnancy test at screening and admission must be negative\n\nExclusion Criteria:\n\n* Weight more than 200kg (441 pounds)\n* Pregnant or breastfeeding\n* Known history of drug or alcohol abuse within the previous year'}, 'identificationModule': {'nctId': 'NCT01296620', 'briefTitle': 'Ulimorelin Study of Efficacy and Safety 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'armGroupLabels': ['Experimental 1']}, {'name': 'Ulimorelin Invtravenously (IV)', 'type': 'DRUG', 'description': '480 µg/kg daily (QD)', 'armGroupLabels': ['Experimental 2']}, {'name': '5% dextrose in water', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Memorial Hospital', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Univ. of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars 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