Clinical trial NCT02544152: Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Takeda
name: Sucampo AG
First posted: 2015-09-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Classified as an Overall Responder for Abdominal Pain
timeFrame: within 12 weeks
Secondary outcomes:
measure: Number of Participants Classified as a Weekly Responder for Abdominal Pain
timeFrame: within 12 weeks
measure: Number of Participants Classified as a Monthly Responder for Abdominal Pain
timeFrame: within 3 months
measure: Number of Participants Classified as a Weekly Responder for Stool Consistency
timeFrame: within 12 weeks
measure: Number of Participants Classified as a Monthly Responder for Stool Consistency
timeFrame: within 3 months
measure: Number of Participants Classified as an Overall Responder for Stool Consistency
timeFrame: within 3 months
measure: Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
timeFrame: within 12 weeks
measure: Number of Participants Classified as a Monthly Responder for IBS Symptoms
timeFrame: within 3 months
measure: Number of Participants Classified as an Overall Responder for IBS Symptoms
timeFrame: within 3 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: E Squared Research, Inc.
state: Alabama
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research Inc.
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Miami
country: United States
facility: Prestige Clinical Research Center
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Concord
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Houston
country: United States
facility: Houston Endoscopy Research Center
state: Texas
city: McKinney
country: United States
facility: Wellness Clinical Research Associates
state: Texas
city: Plano
country: United States
facility: Advanced Clinical Research Associates
state: Texas
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader, MD
role: STUDY_DIRECTOR
References: