A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01494233
First received: December 13, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: 250 mg LX1033 tablets
Drug: Placebo tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in stool consistency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in plasma 5-HIAA levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in worst abdominal pain in past 24 hours [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: February 2012
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
500 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Experimental: Mid dose
500 mg LX1033 three times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Experimental: High dose
1000 mg LX1033 two times daily
Drug: 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
Placebo Comparator: Placebo
Matching placebo dosing
Drug: Placebo tablet
Matching placebo tablet administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
  • 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
  • Ability to provide written, informed consent

Exclusion Criteria:

  • 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.
  • Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
  • Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
  • Any abnormalities or conditions deemed by the investigator as clinically significant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494233

  Show 81 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Sumen Wason, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01494233     History of Changes
Other Study ID Numbers: LX1033.1-201-IBS, LX1033.201
Study First Received: December 13, 2011
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 14, 2014