Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT01494233
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2011-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
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Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis\n* Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)\n* Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale\n* Ability to provide written, informed consent\n\nExclusion Criteria:\n\n* Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.\n* Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week\n* Concomitant use of opioid analgesic drugs or drugs that affect bowel motility\n* Any abnormalities or conditions deemed by the investigator as clinically significant'}, 'identificationModule': {'nctId': 'NCT01494233', 'briefTitle': 'A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)', 'orgStudyIdInfo': {'id': 'LX1033.1-201-IBS'}, 'secondaryIdInfos': [{'id': 'LX1033.201', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose', 'description': '500 mg LX1033 two times daily', 'interventionNames': ['Drug: 250 mg LX1033 tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Mid dose', 'description': '500 mg LX1033 three times daily', 'interventionNames': ['Drug: 250 mg LX1033 tablets']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'description': '1000 mg LX1033 two times daily', 'interventionNames': ['Drug: 250 mg LX1033 tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo dosing', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': '250 mg LX1033 tablets', 'type': 'DRUG', 'description': '250 mg LX1033 tablets administered orally', 'armGroupLabels': ['High dose', 'Low dose', 'Mid dose']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'Matching placebo tablet administered orally', 'armGroupLabels': ['Placebo']}]}, 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