Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
- Conditions
- Opioid-Induced Bowel Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00595946
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 439
- 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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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.
- 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).
- Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- 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.
- Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
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 Mean Weekly Spontaneous Bowel Movements at Week 8 at Week 8 Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.
- Secondary Outcome Measures
Name Time Method Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks within 12 weeks Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose within 48 hours post-dose The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.
Number of Participants Classified as Responders within 12 weeks Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.
Participant Reported Outcome of Treatment Effectiveness within 12 weeks Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity within 12 weeks Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.
Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;
Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best;
Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;
Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;
Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse;
Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse
Trial Locations
- Locations (93)
Orange County Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Apex Medical Research, AMR, Inc.
🇺🇸Flint, Michigan, United States
Medoff Medical/ Vital re:Search
🇺🇸Greensboro, North Carolina, United States
Carolina Pharmaceutical Research
🇺🇸Statesville, North Carolina, United States
Simon Williamson Clinic, PC
🇺🇸Hueytown, Alabama, United States
Clinical Research Advantage, Inc./ Mesa Family Medical Center
🇺🇸Mesa, Arizona, United States
Alabama Orthopedic Clinic
🇺🇸Mobile, Alabama, United States
Verona Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Clinical Research Advantage, Inc.
🇺🇸Tempe, Arizona, United States
Harmony Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸Tucson, Arizona, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Pusch Ridge Family Medicine / WC Clinical Research
🇺🇸Tucson, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Gregory J. Wiener, MD PC
🇺🇸Chula Vista, California, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
RX Clinical Research, Inc
🇺🇸Garden Grove, California, United States
Physicians Clinical Research Corporation
🇺🇸Laguna Hills, California, United States
Loma Linda University Physicians Medical Group
🇺🇸Loma Linda, California, United States
HealthCare Partners Medical Group
🇺🇸Long Beach, California, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
The Regents of the University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Pasadena Rehabilitation Institute
🇺🇸Pasadena, California, United States
SB Family Medicine
🇺🇸Solana Beach, California, United States
Advanced Diagnostic Pain Treatment Center
🇺🇸New Haven, Connecticut, United States
Lynn Institute of Pueblo
🇺🇸Pueblo, Colorado, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
International Research Clinicians of Conneticut
🇺🇸Ridgefield, Connecticut, United States
New England Research Associates, LLC
🇺🇸Trumbull, Connecticut, United States
Century Clinical Research
🇺🇸Daytona Beach, Florida, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
International Medical Research
🇺🇸Daytona Beach, Florida, United States
Clinical Physiology Associates/Clinical Study Center
🇺🇸Fort Myers, Florida, United States
Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
North Georgia Premier Research
🇺🇸Dawsonville, Georgia, United States
Best Clinical Research
🇺🇸Decatur, Georgia, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Pinnacle Trials Inc.
🇺🇸Stockbridge, Georgia, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Saltzer Medical Group
🇺🇸Nampa, Idaho, United States
Millenium Pain Center
🇺🇸Bloomington, Illinois, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Redhead Research Inc., dba Research Associates of Central Illinois
🇺🇸Peoria, Illinois, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC
🇺🇸Lexington, Kentucky, United States
Gulf Coast Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
The Willis-Knighton Pain Management Center
🇺🇸Shreveport, Louisiana, United States
Pain and Rehabilitation Medicine
🇺🇸Bethesda, Maryland, United States
Professional Clinical Research, Benzonia
🇺🇸Benzonia, Michigan, United States
Center for Clinical Studies
🇺🇸Dearborn, Michigan, United States
Digestive Health Specialists, PA
🇺🇸Tupelo, Mississippi, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
University of Nevada
🇺🇸Reno, Nevada, United States
Partners in Primary Care
🇺🇸Voorhees, New Jersey, United States
Abraham D. Morganoff, MD PA
🇺🇸Watchung, New Jersey, United States
Northway Medical Associates
🇺🇸Fulton, New York, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Center for Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Pain Research of Oregon, LLC
🇺🇸Eugene, Oregon, United States
Private Practice of Dr. Hasan
🇺🇸Allentown, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Partners in Clinical Research
🇺🇸Cumberland, Rhode Island, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Trident Institute of Medical Research, LLC
🇺🇸North Charleston, South Carolina, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Southeastern Clinical Research
🇺🇸Chattanooga, Tennessee, United States
Comprehensive Pain Specialists, PLLC
🇺🇸Hendersonville, Tennessee, United States
Integrity Clinical Research, LLC
🇺🇸Savannah, Tennessee, United States
Bexar Clinical Trials, LLC
🇺🇸Richardson, Texas, United States
Dallas VA Research Corporation, Inc.
🇺🇸Dallas, Texas, United States
Salt Lake Research, PLLC
🇺🇸Salt Lake City, Utah, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States
General Clinical Research Center, Virginia Commonwealth University, North Hospital
🇺🇸Richmond, Virginia, United States
Health Sciences Center
🇨🇦Hamilton, Ontario, Canada
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Impact Clinical Trials, Las Vegas
🇺🇸Las Vegas, Nevada, United States
Office of Stephen H. Miller, MD
🇺🇸Las Vegas, Nevada, United States
Diversified Research
🇺🇸Durham, North Carolina, United States
Vanderbilt University - Interventional Pain Center
🇺🇸Nashville, Tennessee, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
University of Rochester
🇺🇸Rochester, New York, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
The Birmingham Pain Center
🇺🇸Birmingham, Alabama, United States
Affinity Research
🇺🇸Portland, Oregon, United States
Metro Physicians a Division of Wheaton Franciscan Medical Group
🇺🇸Milwaukee, Wisconsin, United States
Clement J. Zablocki VA Medical Center
🇺🇸Milwaukee, Wisconsin, United States
UMDNJ
🇺🇸Stratford, New Jersey, United States
Northern California Research Corporation
🇺🇸Sacramento, California, United States