Clinical trial NCT00813098: Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate
timeFrame: Baseline to Week 4
measure: Change From Baseline at Week 4 in Stool Consistency Scores
timeFrame: Baseline to Week 4
measure: Change From Baseline at Week 4 in Stool Frequency
timeFrame: Baseline to Week 4
measure: Change From Baseline at Week 4 on the Severity of Bloating
timeFrame: Baseline to Week 4
measure: Change From Baseline at Week 4 on the Global Improvement Score.
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: Edinger Medical Group Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: AGMG - Orange
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Colorado Springs
country: United States
facility: Lynn Instiute of the Rockies
state: Colorado
city: Boca Raton
country: United States
facility: Clinical Trials Management of Boca Raton, Inc.
state: Florida
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of S. Florida
state: Florida
city: Hialeah
country: United States
facility: Research Consultants Group
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Haverhill
country: United States
facility: ActivMed Practice and Research
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Affiliated Clinical Research
state: Nevada
city: Great Neck
country: United States
facility: Long Island Clinical Research
state: New York
city: Cary
country: United States
facility: Cary Medical Research
state: North Carolina
city: Chapel Hill
country: United States
facility: The UNC Center for Functional GI & Motility Disorders
state: North Carolina
city: Greensboro
country: United States
facility: Medoff Medical/Vital re:Search
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultant of Greater Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Goose Creek
country: United States
facility: Coastal Carolina Research Center in Goose Creek
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Utah Clinical Trials, LLC
state: Utah
city: Norfolk
country: United States
facility: National Clinical Research Norfolk Inc.
state: Virginia
city: Waukesha
country: United States
facility: Aurora Health Center - Waukesha
state: Wisconsin
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Joel P. Freiman, MD
role: STUDY_DIRECTOR
References: