A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant 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 LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494233
• Other study ID #: LX1033.1-201-IBS
• Secondary ID: LX1033.201
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: March 3, 2015
• Start date: February 2012

Study information

• Verified date: March 2015
• 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 objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis

• Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)

• Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale

• Ability to provide written, informed consent

Exclusion Criteria:

• Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.

• Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week

• Concomitant use of opioid analgesic drugs or drugs that affect bowel motility

• Any abnormalities or conditions deemed by the investigator as clinically significant

Study Design

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• 250 mg LX1033 tablets
250 mg LX1033 tablets administered orally
• Placebo tablet
Matching placebo tablet administered orally

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Addison	Illinois
United States	Lexicon Investigational Site	Albuquerque	New Mexico
United States	Lexicon Investigational Site	Anaheim	California
United States	Lexicon Investigational Site	Austin	Texas
United States	Lexicon Investigational Site	Berlin	New Jersey
United States	Lexicon Investigational Site	Billings	Montana
United States	Lexicon Investigational Site	Boise	Idaho
United States	Lexicon Investigational Site	Boone	North Carolina
United States	Lexicon Investigational Site	Bowling Green	Kentucky
United States	Lexicon Investigational Site	Boynton Beach	Florida
United States	Lexicon Investigational Site	Bradenton	Florida
United States	Lexicon Investigational Site	Brockton	Massachusetts
United States	Lexicon Investigational Site	Brooksville	Florida
United States	Lexicon Investigational Site	Cary	North Carolina
United States	Lexicon Investigational Site	Chapel Hill	North Carolina
United States	Lexicon Investigational Site	Chattanooga	Tennessee
United States	Lexicon Investigational Site	Chesterfield	Michigan
United States	Lexicon Investigational Site	Chevy Chase	Maryland
United States	Lexicon Investigational Site	Chicago	Illinois
United States	Lexicon Investigational Site	Clinton	Utah
United States	Lexicon Investigational Site	DeLand	Florida
United States	Lexicon Investigational Site	El Paso	Texas
United States	Lexicon Investigational Site	Encinitas	California
United States	Lexicon Investigational Site	Eugene	Oregon
United States	Lexicon Investigational Site	Fargo	North Dakota
United States	Lexicon Investigational Site	Great Neck	New York
United States	Lexicon Investigational Site	Great Neck	New York
United States	Lexicon Investigational Site	Greensboro	North Carolina
United States	Lexicon Investigational Site	High Point	North Carolina
United States	Lexicon Investigational Site	Huntsville	Alabama
United States	Lexicon Investigational Site	Jackson	Mississippi
United States	Lexicon Investigational Site	Jacksonville	Florida
United States	Lexicon Investigational Site	Kalamazoo	Michigan
United States	Lexicon Investigational Site	Kettering	Ohio
United States	Lexicon Investigational Site	Kissimmee	Florida
United States	Lexicon Investigational Site	Lake Jackson	Texas
United States	Lexicon Investigational Site	Lauderdale Lakes	Florida
United States	Lexicon Investigational Site	Lexington	Kentucky
United States	Lexicon Investigational Site	Lima	Ohio
United States	Lexicon Investigational Site	Little Rock	Arkansas
United States	Lexicon Investigational Site	Littleton	Colorado
United States	Lexicon Investigational Site	Littleton	Colorado
United States	Lexicon Investigational Site	Logan	Utah
United States	Lexicon Investigational Site	Los Angeles	California
United States	Lexicon Investigational Site	Lynchburg	Virginia
United States	Lexicon Investigational Site	Maitland	Florida
United States	Lexicon Investigational Site	Mentor	Ohio
United States	Lexicon Investigational Site	Meridian	Idaho
United States	Lexicon Investigational Site	Mexico	Missouri
United States	Lexicon Investigational Site	Mount Pleasant	South Carolina
United States	Lexicon Investigational Site	New York	New York
United States	Lexicon Investigational Site	Norman	Oklahoma
United States	Lexicon Investigational Site	North Little Rock	Arkansas
United States	Lexicon Investigational Site	Oakland	California
United States	Lexicon Investigational Site	Ogden	Utah
United States	Lexicon Investigational Site	Oklahoma City	Oklahoma
United States	Lexicon Investigational Site	Orange	California
United States	Lexicon Investigational Site	Orlando	Florida
United States	Lexicon Investigational Site	Plano	Texas
United States	Lexicon Investigational Site	Port Orange	Florida
United States	Lexicon Investigational Site	Raleigh	North Carolina
United States	Lexicon Investigational Site	Rockford	Illinois
United States	Lexicon Investigational Site	San Antonio	Texas
United States	Lexicon Investigational Site	San Diego	California
United States	Lexicon Investigational Site	Sandy	Utah
United States	Lexicon Investigational Site	Santa Monica	California
United States	Lexicon Investigational Site	Tampa	Florida
United States	Lexicon Investigational Site	Tempe	Arizona
United States	Lexicon Investigational Site	Towson	Maryland
United States	Lexicon Investigational Site	Troy	Michigan
United States	Lexicon Investigational Site	Tucson	Arizona
United States	Lexicon Investigational Site	Tucson	Arizona
United States	Lexicon Investigational Site	Tustin	California
United States	Lexicon Investigational Site	Virginia Beach	Virginia
United States	Lexicon Investigational Site	Wadsworth	Ohio
United States	Lexicon Investigational Site	Waterbury	Connecticut
United States	Lexicon Investigational Site	West Jordan	Utah
United States	Lexicon Investigational Site	Westlake Village	California
United States	Lexicon Investigational Site	Wheat Ridge	Colorado
United States	Lexicon Investigational Site	Wichita	Kansas
United States	Lexicon Investigational Site	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	Change from baseline in stool consistency		4 weeks	No
Secondary	Change from baseline in plasma 5-HIAA levels		4 weeks	No
Secondary	Change from baseline in worst abdominal pain in past 24 hours		4 weeks	No