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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: 250 mg LX1033 tablets; Drug: Placebo tablet

• Registration Number: NCT01494233
• Lead Sponsor: Lexicon Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Study Start: 2012-02
• Primary Completion: 2013-09
• Status Verified: 2015-03
• Disposition First Submitted: 2015-03-03
• Disposition First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Disposition First Posted: 2015-03-23
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	250 mg LX1033 tablets	1000 mg LX1033 two times daily
Low dose	250 mg LX1033 tablets	500 mg LX1033 two times daily
Placebo	Placebo tablet	Matching placebo dosing
Mid dose	250 mg LX1033 tablets	500 mg LX1033 three times daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in stool consistency	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in worst abdominal pain in past 24 hours	4 weeks
Change from baseline in plasma 5-HIAA levels	4 weeks

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 Virginia Beach, Virginia, United States