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

Opioid-Induced Bowel Dysfunction Clinical Trial

Official title:

A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620061
• Other study ID #: OBD06S1
• Status: Completed
• Phase: Phase 3
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2018
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Intestinal Diseases
• Opioid-Induced Bowel Dysfunction

Intervention

Drug:
• Lubiprostone 24
24 mcg capsules for oral administration

Locations

Country	Name	City	State
Canada	AIM Health Group London North	London	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Health Sciences Centre Pain Clinic	Winnipeg	Manitoba
United States	Lehigh Gastroenterology Associates	Allentown	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Orange County Clinical Trials	Anaheim	California
United States	Advanced Pain Institute	Arcadia	California
United States	Pinnacle Trials Inc.	Atlanta	Georgia
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Pain and Rehabilitation Medicine	Bethesda	Maryland
United States	Impact Clinical Trials	Beverly Hills	California
United States	The Birmingham Pain Center	Birmingham	Alabama
United States	Millenium Pain Center	Bloomington	Illinois
United States	Meridien Research	Brooksville	Florida
United States	Gastroenterology Research Associates, LLC	Cedar Knolls	New Jersey
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Brigham and Women's Hosptial	Chestnut Hill	Massachusetts
United States	Apex Medical Research, AMR, Inc	Chicago	Illinois
United States	University of Illinois at Chicago: Department of Medicine	Chicago	Illinois
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Glenway Family Medicine	Cincinnati	Ohio
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Columbia Medical Practice/ RxTrials, Inc.	Columbia	Maryland
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	North Georgia Premier Research	Dawsonville	Georgia
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Century Clinical Research Inc	Daytona Beach	Florida
United States	International Medical Research	Daytona Beach	Florida
United States	Center for Clinical Studies	Dearborn	Michigan
United States	Best Clinical Research	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	MAPS Applied Research Center	Edina	Minnesota
United States	Central Jersey Medical Research Center	Elizabeth	New Jersey
United States	Pain Research of Oregon, LLC	Eugene	Oregon
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Apex Medical Research, AMR, Inc.	Flint	Michigan
United States	Clinical Physiology Associates/Clinical Study Center	Fort Myers	Florida
United States	Southeastern Integrated Medical, PL dba Florida	Gainesville	Florida
United States	Digestive and Liver Disease Specialists	Garden Grove	California
United States	RX Clinical Research, Inc.	Garden Grove	California
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Carolina Research	Greenville	North Carolina
United States	Comprehensive Pain Specialists, PLLC	Hendersonville	Tennessee
United States	Peters Medical Research, LLC	High Point	North Carolina
United States	Century Clinical Research	Holly Hill	Florida
United States	Arkansas Pain Research	Hot Springs	Arkansas
United States	Simon Williamson Clinic, PC	Hueytown	Alabama
United States	Texas Familicare Clinical Research	Hurst	Texas
United States	Davis Clinic, PC	Indianapolis	Indiana
United States	Professional Clinical Research - Interlochen	Interlochen	Michigan
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Drug Study Institute	Jupiter	Florida
United States	Beyer Research	Kalamazoo	Michigan
United States	Affiliated Clinical Research, Inc.	Las Vegas	Nevada
United States	Impact Clinical Trials	Las Vegas	Nevada
United States	Ladder Family Practice	Las Vegas	Nevada
United States	Office of Stephen H. Miller, MD	Las Vegas	Nevada
United States	Sunrise Medical Research, Inc.	Lauderdale Lakes	Florida
United States	The Pain Treatment Center of the Bluegrass	Lexington	Kentucky
United States	Teton Research, LLC	Little Rock	Arkansas
United States	Loma Linda University	Loma Linda	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Virtua Lumberton Family Physicians	Lumberton	New Jersey
United States	Drug Studies America	Marietta	Georgia
United States	RAS Health Ltd.	Marion	Ohio
United States	Medford Medical Clinic, LLP	Medford	Oregon
United States	Clinical Research Advantage, Inc./ Mesa Family Medical Center	Mesa	Arizona
United States	Integrity Clinical Research, LLC	Milan	Tennessee
United States	VAMC Milwaukee	Milwaukee	Wisconsin
United States	Montana Neuroscience Institute Foundation / Montana Spine and Pain Center	Missoula	Montana
United States	Alabama Orthopedic Clinic	Mobile	Alabama
United States	Advanced Diagnostic Pain Treatment Center	New Haven	Connecticut
United States	NYU Pain Management Center	New York	New York
United States	Research Across America	New York	New York
United States	Kenneth W. Ponder, MD, PA	Niceville	Florida
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Trident Institute of Medical Research, LLC	North Charleston	South Carolina
United States	North Miami Research Inc.	North Miami	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	McBride Clinic	Oklahoma City	Oklahoma
United States	Memorial Clinical Research	Oklahoma City	Oklahoma
United States	Pasadena Rehabilitation Institute	Pasadena	California
United States	Redhead Research Inc.	Peoria	Illinois
United States	Albert Einstein Healthcare Network Einstein Pain Institute	Philadelphia	Pennsylvania
United States	Clinical Research Advantage, Inc.	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	Redpoint Research	Phoenix	Arizona
United States	DMI Health Care Group, Inc.	Pinellas Park	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Affinity Research	Portland	Oregon
United States	Hampton Roads Institution for Performance and Sports Medicine	Portsmouth	Virginia
United States	McGuire VA Medical Center	Richmond	Virginia
United States	University of Rochester, Pain Treatment Center	Rochester	New York
United States	Northern California Research Corporation	Sacramento	California
United States	Medex Healthcare Research Inc.	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Rider Research Group	San Francisco	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	The Willis-Knighton Interventional Pain Center	Shreveport	Louisiana
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Holy Name Hospital	Teaneck	New Jersey
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	Medical Research Associates	Traverse City	Michigan
United States	Center for Digestive Health	Troy	Michigan
United States	Advanced Clinical Therapeutics, LLC	Tucson	Arizona
United States	Genova Clinical Research	Tucson	Arizona
United States	Paradigm Clinical Research, Inc.	Tucson	Arizona
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Verona Clinical Research, Inc.	Tucson	Arizona
United States	Wilson and Charani	Tucson	Arizona
United States	MedVadis Research Corporation	Wellesley Hills	Massachusetts
United States	Intergrated Clinical Trial Services, Inc	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Jeffry A. Lindenbaum DO, PC	Yardley	Pennsylvania
United States	ShahShreenath Clinical Service	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Primary	Mean Weekly Bowel Movements (BMs) Per Month	A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Number of Participants Classified as Monthly Responders	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.	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Straining Associated With Spontaneous Bowel Movements by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Stool Consistency of Spontaneous Bowel Movements by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Constipation Severity by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Abdominal Bloating by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Abdominal Discomfort by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Bowel Habit Regularity by Month	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.	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Treatment Effectiveness by Month	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.	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Mean Weekly Complete SBMs by Month	Participants rate each SBM as complete if their bowels feel completely empty after the SBM	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Mean Weekly Complete BMs by Month	Participants rate each BM as complete if their bowels feel completely empty after the BM	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9