Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
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)
1 other identifier
interventional
71
1 country
16
Brief Summary
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
December 27, 2019
CompletedDecember 27, 2019
March 1, 2018
1.8 years
August 20, 2015
December 6, 2019
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within 12 weeks
Secondary Outcomes (8)
Number of Participants Classified as a Weekly Responder for Abdominal Pain
within 12 weeks
Number of Participants Classified as a Monthly Responder for Abdominal Pain
within 3 months
Number of Participants Classified as a Weekly Responder for Stool Consistency
within 12 weeks
Number of Participants Classified as a Monthly Responder for Stool Consistency
within 3 months
Number of Participants Classified as an Overall Responder for Stool Consistency
within 3 months
- +3 more secondary outcomes
Study Arms (2)
Lubiprostone
EXPERIMENTALParticipants receive 8 mcg lubiprostone capsules twice daily (BID)
Placebo
PLACEBO COMPARATORParticipants receive 0 mcg capsules BID
Interventions
Matching placebo, 0 mcg administered orally twice daily (BID)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Takedacollaborator
- Sucampo AGcollaborator
Study Sites (16)
E Squared Research, Inc.
Huntsville, Alabama, 35801, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
GW Research Inc.
Chula Vista, California, 91910, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Prestige Clinical Research Center
Miami, Florida, 33133, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28210, United States
PMG Research of Charlotte
Concord, North Carolina, 28025, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
Houston Endoscopy Research Center
Houston, Texas, 77079, United States
Wellness Clinical Research Associates
McKinney, Texas, 75071, United States
Advanced Clinical Research Associates
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Global Clinical Leader, MD
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Care provider and outcomes assessor were also blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2015
First Posted
September 9, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 27, 2019
Results First Posted
December 27, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share