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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo tablet; Drug: 250 mg LX1033 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494233

LX1033.201 (Other Identifier)

LX1033.1-201-IBS

Details and patient eligibility

About

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).

Enrollment: 373 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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373 participants in 4 patient groups, including a placebo group

Low dose

Experimental group

Description:

500 mg LX1033 two times daily

Treatment:

Drug: 250 mg LX1033 tablets

Mid dose

Experimental group

Description:

500 mg LX1033 three times daily

Treatment:

Drug: 250 mg LX1033 tablets

High dose

Experimental group

Description:

1000 mg LX1033 two times daily

Treatment:

Drug: 250 mg LX1033 tablets

Placebo

Placebo Comparator group

Description:

Matching placebo dosing

Treatment:

Drug: Placebo tablet