Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: LX1031 High Dose; Drug: LX1031 Low Dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813098

LX1031.201 (Other Identifier)

Protocol LX1031.1-201-IBS

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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155 participants in 3 patient groups, including a placebo group

High dose

Experimental group

Description:

A high dose of LX1031; daily oral intake for 28 days

Treatment:

Drug: LX1031 High Dose

Low Dose

Experimental group

Description:

A low dose of LX1031; daily oral intake for 28 days

Treatment:

Drug: LX1031 Low Dose

Placebo

Placebo Comparator group

Description:

Matching placebo dosing with daily oral intake

Treatment:

Drug: Placebo