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

Phase 2TerminatedNCT02544152

Sucampo Pharma Americas, LLC71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

LubiprostoneDRUG

8 mcg administered orally twice daily (BID)

PlaceboDRUG

Matching placebo, 0 mcg administered orally twice daily (BID)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

E Squared Research, Inc.

Huntsville, Alabama, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Participants Classified as an Overall Responder for Abdominal Pain

An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.

Time frame: within 12 weeks

Secondary Outcomes

Number of Participants Classified as a Weekly Responder for Abdominal Pain

Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse. A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week.

Time frame: within 12 weeks

Number of Participants Classified as a Monthly Responder for Abdominal Pain

A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month.

Time frame: within 3 months

Number of Participants Classified as a Weekly Responder for Stool Consistency

A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week.

Time frame: within 12 weeks

Number of Participants Classified as a Monthly Responder for Stool Consistency

A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month.

Time frame: within 3 months

Number of Participants Classified as an Overall Responder for Stool Consistency

Data from ClinicalTrials.gov

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