Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
- Conditions
- Opioid-Induced Bowel Dysfunction
- Interventions
- Drug: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 437
- 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.
- 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 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
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
Trial Locations
- Locations (113)
Claude Mandel Medical Center
🇺🇸Chicago, Illinois, United States
Jeffry A. Lindenbaum DO, PC
🇺🇸Yardley, Pennsylvania, United States
Hampton Roads Institute for Performance and Sports Medicine (HIPS)
🇺🇸Portsmouth, Virginia, United States
Beth Israel Deaconess Medical Center, Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Catalina Research Institute, LLC
🇺🇸Chino, California, United States
California Pain Center
🇺🇸Huntington Beach, California, United States
Pain Institute of CA
🇺🇸Bakersfield, California, United States
Martin Bowen Hefley Knee
🇺🇸Little Rock, Arkansas, United States
Advanced Pain Institute
🇺🇸Arcadia, California, United States
Shreenath Clinical Service
🇺🇸Laguna Hills, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
Clinical Trial Management of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Drug Study Institute
🇺🇸Jupiter, Florida, United States
Peninsula Research, Inc
🇺🇸Ormond Beach, Florida, United States
North Miami Research, Inc.
🇺🇸North Miami, Florida, United States
Renstar Inc.
🇺🇸Ocala, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Sunrise Medical Research, Inc.
🇺🇸Plantation, Florida, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Q Clinical Research
🇺🇸Decatur, Georgia, United States
Global Research Partners & Consultants, Incs.
🇺🇸Calhoun, Georgia, United States
Advanced Pain Management
🇺🇸Augusta, Georgia, United States
Apex Medical Research, AMR, Inc.
🇺🇸Chicago, Illinois, United States
MediSphere Medical Research Center
🇺🇸Evansville, Indiana, United States
Advanced Pain Care Clinic
🇺🇸Evansville, Indiana, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Rehabilitation Team West, PA
🇺🇸Baltimore, Maryland, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Columbia Medical Practice/ RxTrials, Inc.
🇺🇸Columbia, Maryland, United States
Washington County Hospital Association - The Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
MedVadis Research Corporation
🇺🇸Wellesley Hills, Massachusetts, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States
Holy Name Hospital, Institute for Clinical Research
🇺🇸Teaneck, New Jersey, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Research Across America
🇺🇸New York, New York, United States
North American Partners
🇺🇸Valley Stream, New York, United States
Randolph Medical Associates
🇺🇸Asheboro, North Carolina, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
Southern Gastroenterology Associates
🇺🇸New Bern, North Carolina, United States
Valley Medical Primary Care
🇺🇸Centerville, Ohio, United States
Triangle Medical Research
🇺🇸Lexington, North Carolina, United States
Medford Medical Clinic, LLP
🇺🇸Medford, Oregon, United States
Lehigh Valley Hospital - Neurosciences and Pain Research
🇺🇸Allentown, Pennsylvania, United States
Einstein Pain Institute
🇺🇸Philadelphia, Pennsylvania, United States
Texas Familicare Clinical Research
🇺🇸Hurst, Texas, United States
Integrity Clinical Research, LLC
🇺🇸Milan, Tennessee, United States
Baptist Medical Tower Suite 740
🇺🇸Knoxville, Tennessee, United States
Advance Research Institute
🇺🇸Ogden, Utah, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Bexar Clinical Trials, LLC
🇺🇸Richardson, Texas, United States
Daniel R. Coulston
🇺🇸Spokane, Washington, United States
Northwest Gastroenterology Associates
🇺🇸Bellevue, Washington, United States
Pharmaceutical Integrated Research Company
🇨🇦London, Ontario, Canada
DHC Research
🇨🇦Richmond Hill, Ontario, Canada
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States
Metro Clinical Research, LLC
🇺🇸Littleton, Colorado, United States
Arapahoe Gastroenterology, PC
🇺🇸Littleton, Colorado, United States
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Rider Research Group
🇺🇸San Francisco, California, United States
Lovelace Scientific Resources, Inc.
🇺🇸Las Vegas, Nevada, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Glenway Family Medicine
🇺🇸Cincinnati, Ohio, United States
Memorial Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Paradigm Research Professionals, LLP
🇺🇸Oklahoma City, Oklahoma, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
McGuire Research Institute
🇺🇸Richmond, Virginia, United States
Premiere Pharamaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
Carl T Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
🇺🇸Tempe, Arizona, United States
Tuscaloosa VA Medical Center
🇺🇸Tuscaloosa, Alabama, United States
Harmony Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
HOPE Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Loma Linda University Physicians Medical Group
🇺🇸Loma Linda, California, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Lakewood, Colorado, United States
DMI Research, Inc.
🇺🇸Pinellas Park, Florida, United States
Kenneth W. Ponder, MD PA
🇺🇸Niceville, Florida, United States
Advanced Pain Consultants
🇺🇸Voorhees, New Jersey, United States
Urgent Care Specialists
🇺🇸Dayton, Ohio, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Medex Healthcare Research
🇺🇸Saint Louis, Missouri, United States
Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
🇺🇸Missoula, Montana, United States
Professional Clinical Research, Inc.
🇺🇸Interlochen, Michigan, United States
Gastroenterology Research Associates
🇺🇸Cedar Knolls, New Jersey, United States
MAPS Applied Research Center
🇺🇸Edina, Minnesota, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Michigan, United States
Medical Research Associates
🇺🇸Traverse City, Michigan, United States
PCM Medical Services
🇺🇸Lansing, Michigan, United States
New York University Pain Management Center
🇺🇸New York, New York, United States
Precise Research, Inc.
🇺🇸Flowood, Mississippi, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Toledo - Health Science Campus
🇺🇸Toledo, Ohio, United States
RAS Health Ltd.
🇺🇸Marion, Ohio, United States
Hermitage Medicentre
🇨🇦Edmonton, Alberta, Canada
Davis Clinic, PC
🇺🇸Indianapolis, Indiana, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Gulf Coast Research, LLC
🇺🇸Lafayette, Louisiana, United States
Carolina Digestive Health Associates
🇺🇸Harrisburg, North Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada