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

NCT ID: NCT02544152

Last Updated: 2019-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Care provider and outcomes assessor were also blinded

Study Groups

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Lubiprostone

Participants receive 8 mcg lubiprostone capsules twice daily (BID)

Group Type EXPERIMENTAL

Lubiprostone

Intervention Type DRUG

8 mcg administered orally twice daily (BID)

Placebo

Participants receive 0 mcg capsules BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Lubiprostone

8 mcg administered orally twice daily (BID)

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Amitiza Matching Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Sucampo AG

INDUSTRY

Sponsor Role collaborator

Sucampo Pharma Americas, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader, MD

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

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E Squared Research, Inc.

Huntsville, Alabama, United States

Site Status

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Site Status

GW Research Inc.

Chula Vista, California, United States

Site Status

Inland Empire Liver Foundation

Rialto, California, United States

Site Status

Prestige Clinical Research Center

Miami, Florida, United States

Site Status

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, United States

Site Status

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

PMG Research of Charlotte

Charlotte, North Carolina, United States

Site Status

PMG Research of Charlotte

Concord, North Carolina, United States

Site Status

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Clinical Research Solutions

Jackson, Tennessee, United States

Site Status

Houston Endoscopy Research Center

Houston, Texas, United States

Site Status

Wellness Clinical Research Associates

McKinney, Texas, United States

Site Status

Advanced Clinical Research Associates

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SCMP-0211-201

Identifier Type: -

Identifier Source: org_study_id