Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

Opioid-Induced Bowel Dysfunction Clinical Trial

— OPAL  

Official title:

A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597428
• Other study ID #: OBD0632
• Status: Completed
• Phase: Phase 3
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2015
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lubiprostone
24 mcg capsules twice daily (BID)
• Placebo
0 mcg capsules twice daily (BID)

Locations

Country	Name	City	State
Canada	Hermitage Medicentre	Edmonton	Alberta
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Pharmaceutical Integrated Research Company	London	Ontario
Canada	DHC Research	Richmond Hill	Ontario
Canada	Health Sciences Centre	Winnipeg	Manitoba
United States	Lehigh Valley Hospital - Neurosciences and Pain Research	Allentown	Pennsylvania
United States	Advanced Pain Institute	Arcadia	California
United States	Randolph Medical Associates	Asheboro	North Carolina
United States	Advanced Pain Management	Augusta	Georgia
United States	Pain Institute of CA	Bakersfield	California
United States	Rehabilitation Team West, PA	Baltimore	Maryland
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Clinical Trial Management of Boca Raton, Inc.	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center, Harvard Medical School	Boston	Massachusetts
United States	Global Research Partners & Consultants, Incs.	Calhoun	Georgia
United States	Gastroenterology Research Associates	Cedar Knolls	New Jersey
United States	Valley Medical Primary Care	Centerville	Ohio
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Apex Medical Research, AMR, Inc.	Chicago	Illinois
United States	Claude Mandel Medical Center	Chicago	Illinois
United States	Catalina Research Institute, LLC	Chino	California
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	Columbia Medical Practice/ RxTrials, Inc.	Columbia	Maryland
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Urgent Care Specialists	Dayton	Ohio
United States	Q 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	Advanced Pain Care Clinic	Evansville	Indiana
United States	MediSphere Medical Research Center	Evansville	Indiana
United States	Precise Research, Inc.	Flowood	Mississippi
United States	Carolina Research	Greenville	North Carolina
United States	Washington County Hospital Association - The Center for Clinical Research	Hagerstown	Maryland
United States	Carolina Digestive Health Associates	Harrisburg	North Carolina
United States	Peters Medical Research, LLC	High Point	North Carolina
United States	California Pain Center	Huntington Beach	California
United States	Texas Familicare Clinical Research	Hurst	Texas
United States	Davis Clinic, PC	Indianapolis	Indiana
United States	Professional Clinical Research, Inc.	Interlochen	Michigan
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Drug Study Institute	Jupiter	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Baptist Medical Tower Suite 740	Knoxville	Tennessee
United States	Gulf Coast Research, LLC	Lafayette	Louisiana
United States	Shreenath Clinical Service	Laguna Hills	California
United States	Rocky Mountain Gastroenterology Associates	Lakewood	Colorado
United States	PCM Medical Services	Lansing	Michigan
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Lovelace Scientific Resources, Inc.	Las Vegas	Nevada
United States	Triangle Medical Research	Lexington	North Carolina
United States	Martin Bowen Hefley Knee	Little Rock	Arkansas
United States	Arapahoe Gastroenterology, PC	Littleton	Colorado
United States	Metro Clinical Research, LLC	Littleton	Colorado
United States	Loma Linda University Physicians Medical Group	Loma Linda	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	University of Louisville	Louisville	Kentucky
United States	RAS Health Ltd.	Marion	Ohio
United States	Medford Medical Clinic, LLP	Medford	Oregon
United States	Integrity Clinical Research, LLC	Milan	Tennessee
United States	Montana Neuroscience Institute Foundation / Montana Spine and Pain Center	Missoula	Montana
United States	Delta Research Partners, LLC	Monroe	Louisiana
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Southern Gastroenterology Associates	New Bern	North Carolina
United States	Medex Healthcare Research, Inc.	New York	New York
United States	New York University 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	North Miami Research, Inc.	North Miami	Florida
United States	Renstar Inc.	Ocala	Florida
United States	Advance Research Institute	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Memorial Clinical Research	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals, LLP	Oklahoma City	Oklahoma
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Peninsula Research, Inc	Ormond Beach	Florida
United States	Women's Health Care Specialists, PC	Paw Paw	Michigan
United States	Einstein Pain Institute	Philadelphia	Pennsylvania
United States	Carl T Hayden VA Medical Center	Phoenix	Arizona
United States	HOPE Research Institute, LLC	Phoenix	Arizona
United States	Redpoint Research	Phoenix	Arizona
United States	DMI Research, Inc.	Pinellas Park	Florida
United States	Sunrise Medical Research, Inc.	Plantation	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Hampton Roads Institute for Performance and Sports Medicine (HIPS)	Portsmouth	Virginia
United States	Bexar Clinical Trials, LLC	Richardson	Texas
United States	McGuire Research Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Medex Healthcare Research	Saint Louis	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Highland Clinical Research	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	Rider Research Group	San Francisco	California
United States	Lovelace Scientific Resources, Inc.	Sarasota	Florida
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Daniel R. Coulston	Spokane	Washington
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Holy Name Hospital, Institute for Clinical Research	Teaneck	New Jersey
United States	Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC	Tempe	Arizona
United States	Premiere Pharamaceutical Research, LLC	Tempe	Arizona
United States	University of Toledo - Health Science Campus	Toledo	Ohio
United States	Medical Research Associates	Traverse City	Michigan
United States	Center for Digestive Health	Troy	Michigan
United States	Harmony Clinical Research, Inc.	Tucson	Arizona
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama
United States	North American Partners	Valley Stream	New York
United States	Advanced Pain Consultants	Voorhees	New Jersey
United States	MedVadis Research Corporation	Wellesley Hills	Massachusetts
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	Jeffry A. Lindenbaum DO, PC	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8		Baseline and Week 8
Secondary	Change From Baseline in Mean Weekly SBM Frequency	For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.	Baseline, Week 12, and Weeks 1-12
Secondary	First Post-dose SBM	The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.	24 and 48 hours post-dose
Secondary	Responder Rate	Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.	Up to 12 weeks
Secondary	Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular	Weeks 1-12
Secondary	Treatment Effectiveness	Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective	Weeks 1-12