Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
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
2 other identifiers
interventional
155
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
December 2, 2010
CompletedDecember 2, 2010
November 1, 2010
7 months
December 19, 2008
October 5, 2010
November 4, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate
Baseline to Week 4
Change From Baseline at Week 4 in Stool Consistency Scores
Baseline to Week 4
Change From Baseline at Week 4 in Stool Frequency
Baseline to Week 4
Change From Baseline at Week 4 on the Severity of Bloating
Baseline to Week 4
Change From Baseline at Week 4 on the Global Improvement Score.
Baseline to Week 4
Study Arms (3)
High dose
EXPERIMENTALA high dose of LX1031; daily oral intake for 28 days
Low Dose
EXPERIMENTALA low dose of LX1031; daily oral intake for 28 days
Placebo
PLACEBO COMPARATORMatching placebo dosing with daily oral intake
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Genova Clinical Research
Tucson, Arizona, 85741, United States
Arkansas Gastroenterology
Sherwood, Arkansas, 72120, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Edinger Medical Group Clinical Research Center
Fountain Valley, California, 92708, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
Community Clinical Trials
Orange, California, 92868, United States
AGMG - Orange
Orange, California, 92869, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Lynn Instiute of the Rockies
Colorado Springs, Colorado, 80909, United States
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, 33486, United States
Consultants for Clinical Research of S. Florida
Boynton Beach, Florida, 33426, United States
Research Consultants Group
Hialeah, Florida, 33010, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
ActivMed Practice and Research
Haverhill, Massachusetts, 01830, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89128, United States
Long Island Clinical Research
Great Neck, New York, 11021, United States
Cary Medical Research
Cary, North Carolina, 27518, United States
The UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, 27599, United States
Medoff Medical/Vital re:Search
Greensboro, North Carolina, 27108, United States
Unifour Medical Research
Hickory, North Carolina, 28601, United States
Piedmont Medical Associates
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Gastroenterology Research Consultant of Greater Cincinnati
Cincinnati, Ohio, 45242, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, 29455, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Pioneer Research Solutions
Houston, Texas, 77036, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, 84107, United States
National Clinical Research Norfolk Inc.
Norfolk, Virginia, 23502, United States
Aurora Health Center - Waukesha
Waukesha, Wisconsin, 53186, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Joel P. Freiman, MD
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
December 1, 2008
Primary Completion
July 1, 2009
Study Completion
August 1, 2010
Last Updated
December 2, 2010
Results First Posted
December 2, 2010
Record last verified: 2010-11