Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

Phase 3

Completed

• Conditions: Opioid-Induced Bowel Dysfunction
• Interventions: Drug: Placebo; Drug: Lubiprostone

• Registration Number: NCT00597428
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-06-02
• Disposition First Submitted QC: 2013-02-01
• Disposition First Posted: 2013-02-05
• Results First Submitted: 2013-11-22
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-02
• Results First Posted: 2015-12-07
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

Inclusion Criteria

• Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
• Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
• If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
• Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
• If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
• Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria

• Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
• Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
• Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
• Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
• Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
• Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0 mcg capsules twice daily (BID)
Lubiprostone	Lubiprostone	24 mcg capsules twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8	Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Treatment Effectiveness	Weeks 1-12	Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective
Change From Baseline in Mean Weekly SBM Frequency	Baseline, Week 12, and Weeks 1-12	For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.
First Post-dose SBM	24 and 48 hours post-dose	The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.
Responder Rate	Up to 12 weeks	Number of participants, who remained on treatment for at least 8 weeks, and reported response (\>=3 SBMs) for at least 50% of weeks on study.
Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	Weeks 1-12	Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular

Trial Locations

Locations (113)

Tuscaloosa VA Medical Center; 🇺🇸 Tuscaloosa, Alabama, United States

Carl T Hayden VA Medical Center; 🇺🇸 Phoenix, Arizona, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

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

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

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

Harmony Clinical Research, Inc.; 🇺🇸 Tucson, Arizona, United States

Martin Bowen Hefley Knee; 🇺🇸 Little Rock, Arkansas, United States

Advanced Pain Institute; 🇺🇸 Arcadia, California, United States

Pain Institute of CA; 🇺🇸 Bakersfield, California, United States

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