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

Sponsored by:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00813098

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

Vital signs, hematology, blood chemistry, physical examinations [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Urinalysis [ Time Frame: Biweekly ] [ Designated as safety issue: No ]
ECG and other clinical laboratory assessments [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamic biomarker levels in blood and urine in a subset of subjects [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Diary entries [ Time Frame: Daily ] [ Designated as safety issue: No ]
Global assessments [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High dose: Experimental 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
Low Dose: Experimental 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: Placebo Comparator 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:	Lexicon Pharmaceuticals, Inc. ( Joel P. Freiman, MD, MPH / Medical Director Drug Safety )
Study ID Numbers:	Protocol LX1031.1-201-IBS, LX1031.201
Study First Received:	December 19, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00813098 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on August 28, 2009