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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014