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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813098
• Other study ID #: Protocol LX1031.1-201-IBS
• Secondary ID: LX1031.201
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: November 4, 2010
• Start date: December 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Clinical Trials Management of Boca Raton, Inc.	Boca Raton	Florida
United States	Northwest Clinical Trials	Boise	Idaho
United States	Consultants for Clinical Research of S. Florida	Boynton Beach	Florida
United States	Cary Medical Research	Cary	North Carolina
United States	The UNC Center for Functional GI & Motility Disorders	Chapel Hill	North Carolina
United States	ClinSearch	Chattanooga	Tennessee
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Gastroenterology Research Consultant of Greater Cincinnati	Cincinnati	Ohio
United States	Lynn Instiute of the Rockies	Colorado Springs	Colorado
United States	Edinger Medical Group Clinical Research Center	Fountain Valley	California
United States	Coastal Carolina Research Center in Goose Creek	Goose Creek	South Carolina
United States	Long Island Clinical Research	Great Neck	New York
United States	Medoff Medical/Vital re:Search	Greensboro	North Carolina
United States	ActivMed Practice and Research	Haverhill	Massachusetts
United States	Research Consultants Group	Hialeah	Florida
United States	Unifour Medical Research	Hickory	North Carolina
United States	Houston Medical Research Associates	Houston	Texas
United States	Pioneer Research Solutions	Houston	Texas
United States	Affiliated Clinical Research	Las Vegas	Nevada
United States	Impact Clinical Trials	Los Angeles	California
United States	National Clinical Research Norfolk Inc.	Norfolk	Virginia
United States	Advanced Research Institute	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	AGMG - Orange	Orange	California
United States	Community Clinical Trials	Orange	California
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Utah Clinical Trials, LLC	Salt Lake City	Utah
United States	Medical Associates Research Group	San Diego	California
United States	Arkansas Gastroenterology	Sherwood	Arkansas
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Genova Clinical Research	Tucson	Arizona
United States	Aurora Health Center - Waukesha	Waukesha	Wisconsin
United States	Piedmont Medical Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects Who Experienced Relief of IBS Pain and Discomfort at 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?"	Week 4	No
Secondary	Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate	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.	Baseline to Week 4	No
Secondary	Change From Baseline at Week 4 in Stool Consistency Scores	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.	Baseline to Week 4	No
Secondary	Change From Baseline at Week 4 in Stool Frequency	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.	Baseline to Week 4	No
Secondary	Change From Baseline at Week 4 on the Severity of Bloating	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.	Baseline to Week 4	No
Secondary	Change From Baseline at Week 4 on the Global Improvement Score.	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.	Baseline to Week 4	No