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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT02544152

Run by

Sucampo Pharma Americas, LLC

People needed

71

Starts

2015-02-01

Expected to finish

2016-12-01

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• E Squared Research, Inc. — Huntsville, Alabama, United States
• GW Research Inc. — Chula Vista, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Prestige Clinical Research Center — Miami, Florida, United States
• Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States
• Meritus Center for Clinical Research — Hagerstown, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• PMG Research of Charlotte — Concord, North Carolina, United States
• Cumberland Research Associates, LLC — Fayetteville, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Clinical Research Solutions — Jackson, Tennessee, United States
• Houston Endoscopy Research Center — Houston, Texas, United States
• Wellness Clinical Research Associates — McKinney, Texas, United States
• Advanced Clinical Research Associates — Plano, Texas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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