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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sucampo Pharma Americas, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda
Sucampo AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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