Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments lubiprostone, placebo
Phase phase 2
Sponsor Sucampo AG
Collaborator Sucampo Pharma Americas, LLC
Start date February 2015
End date October 2016
Trial size 71 participants
Trial identifier NCT02544152, SCMP-0211-201

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
8 mcg capsules twice daily (BID)
lubiprostone Amitiza
8 mcg administered orally twice daily (BID)
(Placebo Comparator)
0 mcg capsules twice daily (BID)
placebo No other names
Matching placebo, 0 mcg administered orally twice daily (BID)

Primary Outcomes

Measure
Overall abdominal pain response
time frame: Weeks 1-12

Secondary Outcomes

Measure
Overall assessment of the proportion of subjects reporting ≥50% reduction from baseline in percentage of days with extreme stool consistency (Bristol Stool Form Scale ratings of 1, 2, 6 or 7).
time frame: Weeks 1-12
Weekly assessment of the proportion of subjects reporting ≥50% reduction from baseline in percentage of days with extreme stool consistency (Bristol Stool Form Scale ratings of 1, 2, 6 or 7).
time frame: Weeks 1-12
Monthly assessment of the proportion of subjects reporting ≥50% reduction from baseline in percentage of days with extreme stool consistency (Bristol Stool Form Scale ratings of 1, 2, 6 or 7).
time frame: Month 1-3
Weekly assessment of abdominal pain response.
time frame: Weeks 1-12
Monthly assessment of abdominal pain response.
time frame: Month 1-3
Overall assessment of stool consistency response.
time frame: Weeks 1-12
Weekly assessment of stool consistency response.
time frame: Weeks 1-12
Monthly assessment of stool consistency response.
time frame: Month 1-3
Overall mean change from baseline in abdominal pain
time frame: Weeks 1-12
Overall mean change from baseline in abdominal bloating
time frame: Weeks 1-12
Overall mean change from baseline in straining
time frame: Weeks 1-12
Overall mean change from baseline in stool consistency
time frame: Weeks 1-12
Overall mean change from baseline in improvement of most bothersome IBS symptom
time frame: Weeks 1-12
Weekly mean change from baseline in abdominal pain
time frame: Weeks 1-12
Weekly mean change from baseline in abdominal bloating
time frame: Weeks 1-12
Weekly mean change from baseline in straining
time frame: Weeks 1-12
Weekly mean change from baseline stool consistency
time frame: Weeks 1-12
Weekly mean change from baseline in improvement of most bothersome IBS symptom
time frame: Weeks 1-12
Monthly mean change from baseline in abdominal pain
time frame: Month 1-3
Monthly mean change from baseline in abdominal bloating
time frame: Month 1-3
Monthly mean change from baseline in straining
time frame: Month 1-3
Monthly mean change from baseline in stool consistency
time frame: Month 1-3
Monthly mean change from baseline in improvement of most bothersome IBS symptom
time frame: Month 1-3
Weekly global adequate relief questionnaire
time frame: Weeks 1-12
Overall health-related quality of life (IBS-QoL)
time frame: Weeks 1-12
Overall health-related status (EQ-5D)
time frame: Weeks 1-12

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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)
Principal investigator Charles Barish, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sucampo Pharma Americas, LLC.