Clinical trial NCT01298219: Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
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: 2011-02-17
Enrollment: 439
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 the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.


Eligibility criteria: Inclusion Criteria:

A patient can be considered for eligibility to participate if he/she:

* Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
* Is diagnosed with OBD
* Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
* Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

* Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction

Primary outcomes:
measure: Number of Participants Classified as Treatment Responders Within 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of SBMs Per Week at Week 8
timeFrame: at Week 8
measure: Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
timeFrame: within 48 hours post-dose
measure: Number of SBMs Per Week at Week 12
timeFrame: at Week 12
measure: Number of SBMs Per Week Overall
timeFrame: within 14 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center
state: Alabama
city: Birmingham
country: United States
facility: Innovative Clinical Trials, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Foley
country: United States
facility: G&L Research, LLC
state: Alabama
city: Montgomery
country: United States
facility: Healthscan Research
state: Alabama
city: Tallassee
country: United States
facility: River Region Research
state: Alabama
city: Phoenix
country: United States
facility: Anasazi Internal Medicine PC
state: Arizona
city: Little Rock
country: United States
facility: Aureas Research, Inc
state: Arkansas
city: Carmichael
country: United States
facility: Certified Clinical Research
state: California
city: Davis
country: United States
facility: California Clinical Research, Inc.
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Long Beach
country: United States
facility: Clear Vision Research
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Clear Vision Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Orange
country: United States
facility: SDS Clinical Trials, Inc.
state: California
city: Riverside
country: United States
facility: Probe Clinical Research Corporation
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research Corporation - Santa Ana
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Bradenton
country: United States
facility: Coastal Orthopedics & Pain Management
state: Florida
city: Clearwater
country: United States
facility: Florida Research & Testing, LLC
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: S&W Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Physicians Regional Medical Group
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Ocala
country: United States
facility: Paddock Park Clinical Research
state: Florida
city: Oldsmar
country: United States
facility: Journey Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, DO, PA
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Royal Palm Beach
country: United States
facility: Orthopedic Research Institite
state: Florida
city: Sanford
country: United States
facility: IC Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Pain Care Center
state: Florida
city: Tampa
country: United States
facility: Tampa Clinical Research
state: Florida
city: Columbus
country: United States
facility: Southeastern Regional Research Group
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Boise
country: United States
facility: Sonora Clinical Research
state: Idaho
city: Meridian
country: United States
facility: Nautical Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Anesthesia/Pain Control Indiana University School of Medicine
state: Illinois
city: Peoria
country: United States
facility: Knight Center for Integrated Health
state: Illinois
city: Council Bluffs
country: United States
facility: Ridge Family Practice
state: Iowa
city: Lenexa
country: United States
facility: Lee Research Institute
state: Kansas
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Owensboro
country: United States
facility: Bluegrass Internal Medicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Horizon Research Group
state: Louisiana
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Weymouth
country: United States
facility: Coastal Research
state: Massachusetts
city: Dearborn
country: United States
facility: Ashok Jain, MD
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Medical Associates
state: Michigan
city: Saint Louis
country: United States
facility: Mid-America Clinical Research LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Las Vegas
country: United States
facility: Independent Clinical Researchers
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Lab2Marche
state: Nevada
city: Las Vegas
country: United States
facility: Aloha Medical Center
state: Nevada
city: Edison
country: United States
facility: Edison Medical Group
state: New Jersey
city: Marlton
country: United States
facility: Clinical Research Program
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Jamestown
country: United States
facility: Family Health Medical Services PLLC
state: New York
city: Rochester
country: United States
facility: U of Rochester
state: New York
city: Carlisle
country: United States
facility: Medical Frontiers
state: Ohio
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Parsons Avenue Medical Center
state: Ohio
city: Groveport
country: United States
facility: Hometown Urgent Care
state: Ohio
city: Middleburg Heights
country: United States
facility: Northstar Medical Research, LLC
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherpy Research Associates Inc
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research
state: Oregon
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Mechanicsburg
country: United States
facility: McMillen & Magargle
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Hartwell Research Group
state: South Carolina
city: Greer
country: United States
facility: Degarmo Institute of Medical Research
state: South Carolina
city: North Charleston
country: United States
facility: Pain Specialists of Charleston
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Brentwood
country: United States
facility: InvestiClin Research
state: Tennessee
city: Germantown
country: United States
facility: SCRI Research Center
state: Tennessee
city: Humboldt
country: United States
facility: Prevention & Strengthening Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology & Sleep Lab
state: Texas
city: Austin
country: United States
facility: Jaron Winston, MD
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: Houston
country: United States
facility: Diversified Medical Practice, P.A.
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Dependable Clinical Research
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Richardson
country: United States
facility: Bobby Huynh
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Spring Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: West Jordan
country: United States
facility: ACR Research Salt Lake City
state: Utah
city: Midlothian
country: United States
facility: Virginia Research Center, LLC
state: Virginia
city: Roeselare
country: Belgium
facility: Pain Clinic-Heilig Hart Ziekenhuis Roeselare
state: Westlaan 123
city: Antwerp
country: Belgium
facility: Huisartsenpraktijk De Regenboog
city: Wetteren
country: Belgium
facility: Dr Capiau - GP Practice
city: Brno
country: Czechia
facility: St. Anne's University Hospital - centrum pro
city: Jablonec nad Nisou
country: Czechia
facility: Nemocnice Jablonec nad Nisou, p.o.
city: Liberec
country: Czechia
facility: Ambulance bolesti, Krajska nemocnice Liberec
city: Mlada Boleslav
country: Czechia
facility: Klaudianova nemocnice Mlada Boleslav
city: Praha 10
country: Czechia
facility: Clintrial s.r.o.
city: Praha 6
country: Czechia
facility: Neurologicka ambulance
city: Zlin
country: Czechia
facility: Regional Hospital T. B., a.s.
city: Berlin
country: Germany
facility: Schmerzzentrum Berlin
city: Hannover
country: Germany
facility: Schmerztherapeutische- Ärztezentrum Nordstadt
city: Wiesbaden
country: Germany
facility: Schmerz und Palliativzentrum
city: Bydgoszcz
country: Poland
facility: NZOZ Dom Sue Ryder prowadzony przez Pallmed Sp. z o.o.
city: Gothenburg
country: Sweden
facility: Hagakliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospita- Dept of Anaesthesia, Pain Div.
city: Vällingby
country: Sweden
facility: S3 Clinical Research Centers
city: ELY
country: United Kingdom
facility: ElyBridge Surgery
state: Cardiff
city: Randalstown
country: United Kingdom
facility: Randalstown Medical Practice
state: Co Antrim
city: Bexhill on Sea
country: United Kingdom
facility: Sea Road Surgery
state: E.Sussex
city: Watford
country: United Kingdom
facility: Sheepcot Medical Centre,
state: Herts
city: Blackpool
country: United Kingdom
facility: Fylde Coast Clinical Research Ltd
state: Lancsashire
city: Belfast
country: United Kingdom
facility: Ballygomartin Group Practice
state: Northern Ireland
city: Barry
country: United Kingdom
facility: The Waterfront Medical Centre
state: Wales
city: Dunfermline
country: United Kingdom
facility: Valleyfield Health Center
city: Frome
country: United Kingdom
facility: Frome Medical Practice
city: Reading
country: United Kingdom
facility: Mortimer Surgery
Study officials:
affiliation: Mallinckrodt
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: