Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:February 2015
End Date:December 2016
Contact:Shadreck M Mareya, PhD
Email:info@sucampo.com
Phone:301-961-3400

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A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo,
when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with
IBS-M/IBS-U.

Inclusion Criteria:

- Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III
Diagnostic Questionnaire for Adult Functional GI Disorders.

- Subject Screening diary entries must show an average worst abdominal pain in the past
24 hours score of at least 4 on a 11-point scale.

- Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs),
serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
inhibitors if taking antidepressants.

Exclusion Criteria:

- Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation
(IBS-C), according to Rome III Criteria.

- Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or
defecation.

- Medical/surgical condition that might interfere with the absorption, distribution,
metabolism, or excretion of the study medication.
We found this trial at
21
sites
North Little Rock, Arkansas
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Charlotte, North Carolina 28209
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Charlotte, NC
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Chula Vista, California 91910
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Concord, North Carolina 28025
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Concord, NC
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Fayetteville, North Carolina 28304
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Hagerstown, Maryland 21740
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Houston, TX
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Huntsville, Alabama 35801
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Jackson, Tennessee 38305
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Jackson, TN
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Johns Creek, Georgia 30097
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Johns Creek, GA
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Laguna Hills, California 92653
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Little Rock, Arkansas 72205
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Little Rock, AR
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Los Angeles, CA
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McKinney, TX
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Miami, FL
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Nashville, Tennessee 37205
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Palm Harbor, Florida 34684
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Palm Harbor, FL
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Plano, TX
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Raleigh, NC
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Rialto, California 92377
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Rochester, Minnesota 55905
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Rochester, MN
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