Clinical trial NCT00597428: Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Official title: A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Induced Bowel Dysfunction
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo Pharmaceuticals, Inc.
First posted: 2008-01-18
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in Mean Weekly SBM Frequency
timeFrame: Baseline, Week 12, and Weeks 1-12
measure: First Post-dose SBM
timeFrame: 24 and 48 hours post-dose
measure: Responder Rate
timeFrame: Up to 12 weeks
measure: Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
timeFrame: Weeks 1-12
measure: Treatment Effectiveness
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Carl T Hayden VA Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
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: Premiere Pharamaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Harmony Clinical Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Martin Bowen Hefley Knee
state: Arkansas
city: Arcadia
country: United States
facility: Advanced Pain Institute
state: California
city: Bakersfield
country: United States
facility: Pain Institute of CA
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Huntington Beach
country: United States
facility: California Pain Center
state: California
city: Laguna Hills
country: United States
facility: Shreenath Clinical Service
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Physicians Medical Group
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: San Francisco
country: United States
facility: Rider Research Group
state: California
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastroenterology, PC
state: Colorado
city: Littleton
country: United States
facility: Metro Clinical Research, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Clinical Trial Management of Boca Raton, Inc.
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: Naples
country: United States
facility: Gastroenterology Group of Naples
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: Ocala
country: United States
facility: Renstar Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research, Inc.
state: Florida
city: Plantation
country: United States
facility: Sunrise Medical Research, 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: Sarasota
country: United States
facility: Lovelace Scientific Resources, Inc.
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: Augusta
country: United States
facility: Advanced Pain Management
state: Georgia
city: Calhoun
country: United States
facility: Global Research Partners & Consultants, Incs.
state: Georgia
city: Decatur
country: United States
facility: Q Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Apex Medical Research, AMR, Inc.
state: Illinois
city: Chicago
country: United States
facility: Claude Mandel Medical Center
state: Illinois
city: Evansville
country: United States
facility: Advanced Pain Care Clinic
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Davis Clinic, PC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Lafayette
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Rehabilitation Team West, PA
state: Maryland
city: Columbia
country: United States
facility: Columbia Medical Practice/ RxTrials, Inc.
state: Maryland
city: Hagerstown
country: United States
facility: Washington County Hospital Association - The Center for Clinical Research
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard Medical School
state: Massachusetts
city: Wellesley Hills
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research, Inc.
state: Michigan
city: Lansing
country: United States
facility: PCM Medical Services
state: Michigan
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
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: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Flowood
country: United States
facility: Precise Research, Inc.
state: Mississippi
city: Saint Louis
country: United States
facility: Medex Healthcare Research
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience Institute Foundation / Montana Spine and Pain Center
state: Montana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Nevada
city: Cedar Knolls
country: United States
facility: Gastroenterology Research Associates
state: New Jersey
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital, Institute for Clinical Research
state: New Jersey
city: Voorhees
country: United States
facility: Advanced Pain Consultants
state: New Jersey
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: New York
country: United States
facility: New York University Pain Management Center
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: Valley Stream
country: United States
facility: North American Partners
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Asheboro
country: United States
facility: Randolph Medical Associates
state: North Carolina
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: Harrisburg
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Lexington
country: United States
facility: Triangle Medical Research
state: North Carolina
city: New Bern
country: United States
facility: Southern Gastroenterology Associates
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
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: Urgent Care Specialists
state: Ohio
city: Marion
country: United States
facility: RAS Health Ltd.
state: Ohio
city: Toledo
country: United States
facility: University of Toledo - Health Science Campus
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLP
state: Oklahoma
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Neurosciences and Pain Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Pain Institute
state: Pennsylvania
city: Yardley
country: United States
facility: Jeffry A. Lindenbaum DO, PC
state: Pennsylvania
city: Knoxville
country: United States
facility: Baptist Medical Tower Suite 740
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: Richardson
country: United States
facility: Bexar Clinical Trials, LLC
state: Texas
city: Ogden
country: United States
facility: Advance Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Portsmouth
country: United States
facility: Hampton Roads Institute for Performance and Sports Medicine (HIPS)
state: Virginia
city: Richmond
country: United States
facility: McGuire Research Institute
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Spokane
country: United States
facility: Daniel R. Coulston
state: Washington
city: Edmonton
country: Canada
facility: Hermitage Medicentre
state: Alberta
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: Pharmaceutical Integrated Research Company
state: Ontario
city: Richmond Hill
country: Canada
facility: DHC Research
state: Ontario
Study officials:
affiliation: MedVadis Research Corporation
name: Egilius L.H. Spierings, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: