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

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • E Squared Research, Inc.
  • Arkansas Gastroenterology
  • GW Research Inc.
  • Inland Empire Liver Foundation
  • Prestige Clinical Research Center
  • Advanced Gastroenterology Associates, LLC
  • Meritus Center for Clinical Research
  • Mayo Clinic
  • PMG Research of Charlotte
  • PMG Research of Charlotte
  • Cumberland Research Associates, LLC
  • Wake Research Associates, LLC
  • Clinical Research Solutions
  • Houston Endoscopy Research Center
  • Wellness Clinical Research Associates
  • Advanced Clinical Research Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lubiprostone

Placebo

Arm Description

Participants receive 8 mcg lubiprostone capsules twice daily (BID)

Participants receive 0 mcg capsules BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 20, 2015
Last Updated
December 6, 2019
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Takeda, Sucampo AG
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1. Study Identification

Unique Protocol Identification Number
NCT02544152
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Takeda, Sucampo AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Care provider and outcomes assessor were also blinded
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
Participants receive 8 mcg lubiprostone capsules twice daily (BID)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive 0 mcg capsules BID
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
8 mcg administered orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Matching placebo, 0 mcg administered orally twice daily (BID)
Primary Outcome Measure Information:
Title
Number of Participants Classified as an Overall Responder for Abdominal Pain
Description
An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
Time Frame
within 12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Classified as a Weekly Responder for Abdominal Pain
Description
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.
Time Frame
within 12 weeks
Title
Number of Participants Classified as a Monthly Responder for Abdominal Pain
Description
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.
Time Frame
within 3 months
Title
Number of Participants Classified as a Weekly Responder for Stool Consistency
Description
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.
Time Frame
within 12 weeks
Title
Number of Participants Classified as a Monthly Responder for Stool Consistency
Description
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.
Time Frame
within 3 months
Title
Number of Participants Classified as an Overall Responder for Stool Consistency
Description
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.
Time Frame
within 3 months
Title
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms
Description
A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.
Time Frame
within 12 weeks
Title
Number of Participants Classified as a Monthly Responder for IBS Symptoms
Description
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.
Time Frame
within 3 months
Title
Number of Participants Classified as an Overall Responder for IBS Symptoms
Description
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.
Time Frame
within 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
E Squared Research, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
GW Research Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Prestige Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Meritus Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PMG Research of Charlotte
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Houston Endoscopy Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Wellness Clinical Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Advanced Clinical Research Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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