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

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02544152
• Other study ID #: SCMP-0211-201
• Status: Terminated
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Lubiprostone
8 mcg administered orally twice daily (BID)
• Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)

Locations

Country	Name	City	State
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	GW Research Inc.	Chula Vista	California
United States	PMG Research of Charlotte	Concord	North Carolina
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Houston Endoscopy Research Center	Houston	Texas
United States	E Squared Research, Inc.	Huntsville	Alabama
United States	Clinical Research Solutions	Jackson	Tennessee
United States	Wellness Clinical Research Associates	McKinney	Texas
United States	Prestige Clinical Research Center	Miami	Florida
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	Advanced Clinical Research Associates	Plano	Texas
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Inland Empire Liver Foundation	Rialto	California
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo AG, Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Classified as a Weekly Responder for Abdominal Pain	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
Secondary	Number of Participants Classified as a Monthly Responder for Abdominal Pain	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
Secondary	Number of Participants Classified as a Weekly Responder for Stool Consistency	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
Secondary	Number of Participants Classified as a Monthly Responder for Stool Consistency	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
Secondary	Number of Participants Classified as an Overall Responder for Stool Consistency	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
Secondary	Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms	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
Secondary	Number of Participants Classified as a Monthly Responder for IBS Symptoms	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
Secondary	Number of Participants Classified as an Overall Responder for IBS Symptoms	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