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

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: LX1031 High Dose Drug: LX1031 Low Dose Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:

Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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 Outcome Measures:

Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Week 4 in Stool Consistency Scores [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Week 4 in Stool Frequency [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Week 4 on the Severity of Bloating [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Week 4 on the Global Improvement Score. [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
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.

Enrollment:	155
Study Start Date:	December 2008
Study Completion Date:	August 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High dose A high dose of LX1031; daily oral intake for 28 days	Drug: LX1031 High Dose A high dose of LX1031; daily oral intake for 28 days
Experimental: Low Dose A low dose of LX1031; daily oral intake for 28 days	Drug: LX1031 Low Dose A low dose of LX1031; daily oral intake for 28 days.
Placebo Comparator: Placebo Matching placebo dosing with daily oral intake	Drug: Placebo Matching placebo dosing with daily oral intake

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813098

Show 36 Study Locations

Sponsors and Collaborators

Lexicon Pharmaceuticals

Investigators

Study Director:

Joel P. Freiman, MD

Lexicon Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Joel P. Freiman, MD, MPH / Medical Director Drug Safety, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00813098 History of Changes
Other Study ID Numbers:	Protocol LX1031.1-201-IBS, LX1031.201
Study First Received:	December 19, 2008
Results First Received:	October 5, 2010
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013