Phase 2
N=155
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00813098 ↗Enrolled (actual)
155
Serious AEs
0.7%
Results posted
Dec 2010
Primary outcome: Primary: Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 — 23; 18; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LX1031 High Dose (Drug); LX1031 Low Dose (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexicon Pharmaceuticals
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 |
23; 18; 20 | — |
| SECONDARY Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate |
-0.32; -0.26; -0.33 | — |
| SECONDARY Change From Baseline at Week 4 in Stool Consistency Scores |
-1.11; -0.30; -0.56 | — |
| SECONDARY Change From Baseline at Week 4 in Stool Frequency |
-0.75; -0.52; -0.62 | — |
| SECONDARY Change From Baseline at Week 4 on the Severity of Bloating |
-18.68; -15.13; -15.48 | — |
| SECONDARY Change From Baseline at Week 4 on the Global Improvement Score. |
1.56; 1.33; 1.47 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00813098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.