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Completed

NCT Number: NCT01494233

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

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lexicon Investigational Site, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

250 mg LX1033 tablets

Drug

250 mg LX1033 tablets administered orally

Placebo Tablet

Drug

Matching placebo tablet administered orally

Primary outcomes

  1. Change from baseline in stool consistency

    Time frame: 4 weeks

Secondary outcomes

  1. Change from baseline in plasma 5-HIAA levels

    Time frame: 4 weeks

  2. Change from baseline in worst abdominal pain in past 24 hours

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Important dates

Study start
2012
Primary completion
2013
First posted
Dec 16, 2011
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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