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Completed

NCT Number: NCT00813098

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

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.

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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

Genova Clinical Research, Tucson, Arizona, 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

  • 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)

Treatment and study plan

LX1031 High Dose

Drug

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

LX1031 Low Dose

Drug

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

Placebo

Drug

Matching placebo dosing with daily oral intake

Primary outcomes

  1. 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

  1. Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate

    Time frame: Baseline to Week 4

    To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,"Have you felt or experienced a sense of urgency to pass stool today?" The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline.

  2. Change From Baseline at Week 4 in Stool Consistency Scores

    Time frame: Baseline to Week 4

    Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.

  3. Change From Baseline at Week 4 in Stool Frequency

    Time frame: Baseline to Week 4

    Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.

  4. Change From Baseline at Week 4 on the Severity of Bloating

    Time frame: Baseline to Week 4

    Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being "not at all" and 100 mm being "worst possible"). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating.

  5. Change From Baseline at Week 4 on the Global Improvement Score.

    Time frame: Baseline to Week 4

    The IBS Global Improvement Scale (IBS-GAI) asks "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved?" The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score.

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 LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 22, 2008
Registry last updated
Dec 2, 2010

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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