Clinical trial NCT01494233: A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant 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 LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 373
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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in stool consistency
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in plasma 5-HIAA levels
timeFrame: 4 weeks
measure: Change from baseline in worst abdominal pain in past 24 hours
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Lexicon Investigational Site
state: Alabama
city: Tempe
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Lexicon Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Lexicon Investigational Site
state: Arkansas
city: North Little Rock
country: United States
facility: Lexicon Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Lexicon Investigational Site
state: California
city: Encinitas
country: United States
facility: Lexicon Investigational Site
state: California
city: Los Angeles
country: United States
facility: Lexicon Investigational Site
state: California
city: Oakland
country: United States
facility: Lexicon Investigational Site
state: California
city: Orange
country: United States
facility: Lexicon Investigational Site
state: California
city: San Diego
country: United States
facility: Lexicon Investigational Site
state: California
city: Santa Monica
country: United States
facility: Lexicon Investigational Site
state: California
city: Tustin
country: United States
facility: Lexicon Investigational Site
state: California
city: Westlake Village
country: United States
facility: Lexicon Investigational Site
state: California
city: Littleton
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Lexicon Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: DeLand
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Maitland
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Tampa
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Boise
country: United States
facility: Lexicon Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Lexicon Investigational Site
state: Idaho
city: Addison
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Lexicon Investigational Site
state: Kansas
city: Bowling Green
country: United States
facility: Lexicon Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Lexicon Investigational Site
state: Kentucky
city: Chevy Chase
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Towson
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Brockton
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Troy
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Lexicon Investigational Site
state: Mississippi
city: Mexico
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Billings
country: United States
facility: Lexicon Investigational Site
state: Montana
city: Berlin
country: United States
facility: Lexicon Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Lexicon Investigational Site
state: New Mexico
city: Great Neck
country: United States
facility: Lexicon Investigational Site
state: New York
city: Great Neck
country: United States
facility: Lexicon Investigational Site
state: New York
city: New York
country: United States
facility: Lexicon Investigational Site
state: New York
city: Boone
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Cary
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Lexicon Investigational Site
state: North Dakota
city: Kettering
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Lima
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Norman
country: United States
facility: Lexicon Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lexicon Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Lexicon Investigational Site
state: Oregon
city: Mount Pleasant
country: United States
facility: Lexicon Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: El Paso
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Plano
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Clinton
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Logan
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Ogden
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Sandy
country: United States
facility: Lexicon Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Lexicon Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Lexicon Investigational Site
state: Virginia
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Sumen Wason, MD
role: STUDY_DIRECTOR
References:
citation: Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Therap Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.