A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 155
- Locations
- 36
- Primary Endpoint
- Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
Study Overview
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females aged 18-70 years old
- •Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
- •Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
- •Normal structural evaluation of the colon within 5 years prior to screening
- •Ability to provide written informed consent
Exclusion Criteria
- •Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
- •Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
- •Lactose intolerance
- •Major psychological disorder
- •Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)
Arms & Interventions
Placebo
Matching placebo dosing with daily oral intake
Intervention: Placebo (Drug)
High dose
A high dose of LX1031; daily oral intake for 28 days
Intervention: LX1031 High Dose (Drug)
Low Dose
A low dose of LX1031; daily oral intake for 28 days
Intervention: LX1031 Low Dose (Drug)
Outcomes
Primary Outcomes
Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
Time Frame: Week 4
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"
Secondary Outcomes
- Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate(Baseline to Week 4)
- Change From Baseline at Week 4 in Stool Consistency Scores(Baseline to Week 4)
- Change From Baseline at Week 4 on the Severity of Bloating(Baseline to Week 4)
- Change From Baseline at Week 4 on the Global Improvement Score.(Baseline to Week 4)
- Change From Baseline at Week 4 in Stool Frequency(Baseline to Week 4)