Clinical trial NCT00620061: Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Official title: A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Induced Bowel Dysfunction
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Mean Weekly Bowel Movements (BMs) Per Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary outcomes:
measure: Number of Participants Classified as Monthly Responders
timeFrame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Straining Associated With Spontaneous Bowel Movements by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Stool Consistency of Spontaneous Bowel Movements by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Constipation Severity by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Abdominal Bloating by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Abdominal Discomfort by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Bowel Habit Regularity by Month
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Treatment Effectiveness by Month
timeFrame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Mean Weekly Complete SBMs by Month
timeFrame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Mean Weekly Complete BMs by Month
timeFrame: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Birmingham Pain Center
state: Alabama
city: Hueytown
country: United States
facility: Simon Williamson Clinic, PC
state: Alabama
city: Mobile
country: United States
facility: Alabama Orthopedic Clinic
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./ Mesa Family Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharamaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Verona Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics, LLC
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Tucson
country: United States
facility: Wilson and Charani
state: Arizona
city: Hot Springs
country: United States
facility: Arkansas Pain Research
state: Arkansas
city: Little Rock
country: United States
facility: Teton Research, LLC
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Arcadia
country: United States
facility: Advanced Pain Institute
state: California
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialists
state: California
city: Garden Grove
country: United States
facility: RX Clinical Research, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Pasadena
country: United States
facility: Pasadena Rehabilitation Institute
state: California
city: Sacramento
country: United States
facility: Northern California Research Corporation
state: California
city: San Francisco
country: United States
facility: Rider Research Group
state: California
city: Yorba Linda
country: United States
facility: ShahShreenath Clinical Service
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: New Haven
country: United States
facility: Advanced Diagnostic Pain Treatment Center
state: Connecticut
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Daytona Beach
country: United States
facility: Century Clinical Research Inc
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates/Clinical Study Center
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL dba Florida
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research, Inc.
state: Florida
city: Niceville
country: United States
facility: Kenneth W. Ponder, MD, PA
state: Florida
city: North Miami
country: United States
facility: North Miami Research Inc.
state: Florida
city: Pinellas Park
country: United States
facility: DMI Health Care Group, Inc.
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials Inc.
state: Georgia
city: Dawsonville
country: United States
facility: North Georgia Premier Research
state: Georgia
city: Decatur
country: United States
facility: Best Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Bloomington
country: United States
facility: Millenium Pain Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago: Department of Medicine
state: Illinois
city: Chicago
country: United States
facility: Apex Medical Research, AMR, Inc
state: Illinois
city: Peoria
country: United States
facility: Redhead Research Inc.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Davis Clinic, PC
state: Indiana
city: West Des Moines
country: United States
facility: Intergrated Clinical Trial Services, Inc
state: Iowa
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Shreveport
country: United States
facility: The Willis-Knighton Interventional Pain Center
state: Louisiana
city: Bethesda
country: United States
facility: Pain and Rehabilitation Medicine
state: Maryland
city: Columbia
country: United States
facility: Columbia Medical Practice/ RxTrials, Inc.
state: Maryland
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hosptial
state: Massachusetts
city: Wellesley Hills
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Dearborn
country: United States
facility: Center for Clinical Studies
state: Michigan
city: Flint
country: United States
facility: Apex Medical Research, AMR, Inc.
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research - Interlochen
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Traverse City
country: United States
facility: Medical Research Associates
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center
state: Minnesota
city: Saint Louis
country: United States
facility: Medex Healthcare Research Inc.
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
state: Montana
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, MD
state: Nevada
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Ladder Family Practice
state: Nevada
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Cedar Knolls
country: United States
facility: Gastroenterology Research Associates, LLC
state: New Jersey
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Lumberton
country: United States
facility: Virtua Lumberton Family Physicians
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: NYU Pain Management Center
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: Rochester
country: United States
facility: University of Rochester, Pain Treatment Center
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Glenway Family Medicine
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Marion
country: United States
facility: RAS Health Ltd.
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: McBride Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Eugene
country: United States
facility: Pain Research of Oregon, LLC
state: Oregon
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Portland
country: United States
facility: Affinity Research
state: Oregon
city: Allentown
country: United States
facility: Lehigh Gastroenterology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network Einstein Pain Institute
state: Pennsylvania
city: Yardley
country: United States
facility: Jeffry A. Lindenbaum DO, PC
state: Pennsylvania
city: North Charleston
country: United States
facility: Trident Institute of Medical Research, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists, PLLC
state: Tennessee
city: Milan
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: Hurst
country: United States
facility: Texas Familicare Clinical Research
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Portsmouth
country: United States
facility: Hampton Roads Institution for Performance and Sports Medicine
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Milwaukee
country: United States
facility: VAMC Milwaukee
state: Wisconsin
city: Winnipeg
country: Canada
facility: Health Sciences Centre Pain Clinic
state: Manitoba
city: London
country: Canada
facility: AIM Health Group London North
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: