Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

Opioid-induced Bowel Dysfunction Clinical Trial

Official title:

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298219
• Other study ID #: OBD1033
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: February 2013
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lubiprostone
24 mcg administered orally twice daily (BID)
• Placebo
Matching placebo, 0 mcg administered orally twice daily (BID)

Locations

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

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Germany,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Classified as Treatment Responders Within 12 Weeks	Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (= 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (= 3 SBMs per week) for at least 9 of the 12 treatment weeks.	12 weeks
Secondary	Number of SBMs Per Week at Week 8		at Week 8
Secondary	Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation		within 48 hours post-dose
Secondary	Number of SBMs Per Week at Week 12		at Week 12
Secondary	Number of SBMs Per Week Overall	Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.	within 14 weeks