Clinical trial NCT00595946: 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: 2008-01-16
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 this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.


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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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:

* 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).
* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
* 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.
* Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

Primary outcomes:
measure: Mean Weekly Spontaneous Bowel Movements at Week 8
timeFrame: at Week 8
Secondary outcomes:
measure: Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
timeFrame: within 12 weeks
measure: Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
timeFrame: within 48 hours post-dose
measure: Number of Participants Classified as Responders
timeFrame: within 12 weeks
measure: Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
timeFrame: within 12 weeks
measure: Participant Reported Outcome of Treatment Effectiveness
timeFrame: within 12 weeks
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: Tempe
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Tucson
country: United States
facility: Harmony Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Verona 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: Genova Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Pusch Ridge Family Medicine / WC Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials, Inc.
state: California
city: Chula Vista
country: United States
facility: Gregory J. Wiener, MD PC
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: Laguna Hills
country: United States
facility: Physicians Clinical Research Corporation
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Physicians Medical Group
state: California
city: Long Beach
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Los Angeles
country: United States
facility: The Regents of the University of California, Los Angeles
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: Solana Beach
country: United States
facility: SB Family Medicine
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Pueblo
country: United States
facility: Lynn Institute of Pueblo
state: Colorado
city: New Haven
country: United States
facility: Advanced Diagnostic Pain Treatment Center
state: Connecticut
city: Ridgefield
country: United States
facility: International Research Clinicians of Conneticut
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Clermont
country: United States
facility: South Lake Pain Institute
state: Florida
city: Daytona Beach
country: United States
facility: Century Clinical Research
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: Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
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: Stockbridge
country: United States
facility: Pinnacle Trials Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Bloomington
country: United States
facility: Millenium Pain Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
city: Peoria
country: United States
facility: Redhead Research Inc., dba Research Associates of Central Illinois
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: The Willis-Knighton Pain Management Center
state: Louisiana
city: Bethesda
country: United States
facility: Pain and Rehabilitation Medicine
state: Maryland
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Benzonia
country: United States
facility: Professional Clinical Research, Benzonia
state: Michigan
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: Tupelo
country: United States
facility: Digestive Health Specialists, PA
state: Mississippi
city: Las Vegas
country: United States
facility: Impact Clinical Trials, Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, MD
state: Nevada
city: Reno
country: United States
facility: University of Nevada
state: Nevada
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Stratford
country: United States
facility: UMDNJ
state: New Jersey
city: Voorhees
country: United States
facility: Partners in Primary Care
state: New Jersey
city: Watchung
country: United States
facility: Abraham D. Morganoff, MD PA
state: New Jersey
city: Fulton
country: United States
facility: Northway Medical Associates
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Diversified Research
state: North Carolina
city: Greensboro
country: United States
facility: Medoff Medical/ Vital re:Search
state: North Carolina
city: Statesville
country: United States
facility: Carolina Pharmaceutical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research, LLC
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Eugene
country: United States
facility: Pain Research of Oregon, LLC
state: Oregon
city: Portland
country: United States
facility: Affinity Research
state: Oregon
city: Allentown
country: United States
facility: Private Practice of Dr. Hasan
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
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: Nashville
country: United States
facility: Vanderbilt University - Interventional Pain Center
state: Tennessee
city: Savannah
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Research Corporation, Inc.
state: Texas
city: Dallas
country: United States
facility: Bexar Clinical Trials, LLC
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: Richardson
country: United States
facility: Bexar Clinical Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research, PLLC
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: General Clinical Research Center, Virginia Commonwealth University, North Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Metro Physicians a Division of Wheaton Franciscan Medical Group
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center
state: Wisconsin
city: Hamilton
country: Canada
facility: Health Sciences Center
state: Ontario
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
citation: Cryer B, Katz S, Vallejo R, Popescu A, Ueno R. A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain. Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.