Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

Phase 3

Completed

• Conditions: Opioid-Induced Bowel Dysfunction
• Interventions: Drug: Lubiprostone 24

• Registration Number: NCT00620061
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-21
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Disposition First Submitted: 2011-03-04
• Disposition First Submitted QC: 2013-02-01
• Disposition First Posted: 2013-02-05
• Results First Submitted: 2016-07-12
• Status Verified: 2018-03
• Results First Submitted QC: 2019-12-12
• Results First Posted: 2019-12-30
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 439

Inclusion Criteria

• Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
• Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
• Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria

• Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
• Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
• Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Lubiprostone 24	Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks

Primary Outcome Measures

Name	Time	Method
Mean Weekly Bowel Movements (BMs) Per Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.

Secondary Outcome Measures

Name	Time	Method
Straining Associated With Spontaneous Bowel Movements by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Abdominal Discomfort by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.; The highest score is 4, but the best score is 0.
Treatment Effectiveness by Month	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.; The highest and best score is 4.
Number of Participants Classified as Monthly Responders	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).; A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Stool Consistency of Spontaneous Bowel Movements by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Constipation Severity by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.; The highest score is 4, but the best score is 0.
Abdominal Bloating by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.; The highest score is 4, but the best score is 0.
Bowel Habit Regularity by Month	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.; The highest score is 7, but the best score is 1.
Mean Weekly Complete SBMs by Month	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Mean Weekly Complete BMs by Month	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9	Participants rate each BM as complete if their bowels feel completely empty after the BM

Trial Locations

Locations (119)

The Birmingham Pain Center; 🇺🇸 Birmingham, Alabama, United States

Simon Williamson Clinic, PC; 🇺🇸 Hueytown, Alabama, United States

Alabama Orthopedic Clinic; 🇺🇸 Mobile, Alabama, United States

Clinical Research Advantage, Inc./ Mesa Family Medical Center; 🇺🇸 Mesa, Arizona, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Clinical Research Advantage, Inc.; 🇺🇸 Tempe, Arizona, United States

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC; 🇺🇸 Tempe, Arizona, United States

Premiere Pharamaceutical Research, LLC; 🇺🇸 Tempe, Arizona, United States

Genova Clinical Research; 🇺🇸 Tucson, Arizona, United States

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