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

December 6, 2019 updated by: Sucampo Pharma Americas, LLC

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • E Squared Research, Inc.
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Chula Vista, California, United States, 91910
        • GW Research Inc.
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
    • Florida
      • Miami, Florida, United States, 33133
        • Prestige Clinical Research Center
      • Palm Harbor, Florida, United States, 34684
        • Advanced Gastroenterology Associates, LLC
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • PMG Research of Charlotte
      • Concord, North Carolina, United States, 28025
        • PMG Research of Charlotte
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions
    • Texas
      • Houston, Texas, United States, 77079
        • Houston Endoscopy Research Center
      • McKinney, Texas, United States, 75071
        • Wellness Clinical Research Associates
      • Plano, Texas, United States, 75093
        • Advanced Clinical Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lubiprostone
Participants receive 8 mcg lubiprostone capsules twice daily (BID)
Drug: Lubiprostone
8 mcg administered orally twice daily (BID)
Other Names:
  • Amitiza
Placebo Comparator: Placebo
Participants receive 0 mcg capsules BID
Drug: Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)
Other Names:
  • Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Classified as an Overall Responder for Abdominal Pain
Time Frame: within 12 weeks
An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
within 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Classified as a Weekly Responder for Abdominal Pain
Time Frame: within 12 weeks

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.
within 12 weeks
Number of Participants Classified as a Monthly Responder for Abdominal Pain
Time Frame: within 3 months
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.
within 3 months
Number of Participants Classified as a Weekly Responder for Stool Consistency
Time Frame: within 12 weeks
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.
within 12 weeks
Number of Participants Classified as a Monthly Responder for Stool Consistency
Time Frame: within 3 months
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.
within 3 months
Number of Participants Classified as an Overall Responder for Stool Consistency
Time Frame: within 3 months
An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks.
within 3 months
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
Time Frame: within 12 weeks
A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.
within 12 weeks
Number of Participants Classified as a Monthly Responder for IBS Symptoms
Time Frame: within 3 months
A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms.
within 3 months
Number of Participants Classified as an Overall Responder for IBS Symptoms
Time Frame: within 3 months
A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms.
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

Collaborators

Takeda
Sucampo AG

Investigators

  • Study Director: Global Clinical Leader, MD, Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMP-0211-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Lubiprostone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe