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

Sucampo

Status and phase

Terminated

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Placebo

Drug: Lubiprostone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02544152

SCMP-0211-201

Details and patient eligibility

About

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

Full description

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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.