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: NCT00595946
• Other study ID #: OBD0631
• Status: Completed
• Phase: Phase 3
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: December 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• 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 (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.

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	Health Sciences Center	Hamilton	Ontario
United States	Private Practice of Dr. Hasan	Allentown	Pennsylvania
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Orange County Clinical Trials, Inc.	Anaheim	California
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	Professional Clinical Research, Benzonia	Benzonia	Michigan
United States	Pain and Rehabilitation Medicine	Bethesda	Maryland
United States	The Birmingham Pain Center	Birmingham	Alabama
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Millenium Pain Center	Bloomington	Illinois
United States	The Brigham and Women's Hospital	Boston	Massachusetts
United States	Meridien Research	Brooksville	Florida
United States	Cooper Health System	Camden	New Jersey
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	University of Illinois Medical Center	Chicago	Illinois
United States	Gregory J. Wiener, MD PC	Chula Vista	California
United States	South Lake Pain Institute	Clermont	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Partners in Clinical Research	Cumberland	Rhode Island
United States	Bexar Clinical Trials, LLC	Dallas	Texas
United States	Dallas VA Research Corporation, Inc.	Dallas	Texas
United States	North Georgia Premier Research	Dawsonville	Georgia
United States	Century Clinical Research	Daytona Beach	Florida
United States	International Medical Research	Daytona Beach	Florida
United States	Center for Clinical Studies	Dearborn	Michigan
United States	Best Clinical Research	Decatur	Georgia
United States	Diversified Research	Durham	North Carolina
United States	Pain Research of Oregon, LLC	Eugene	Oregon
United States	Apex Medical Research, AMR, Inc.	Flint	Michigan
United States	Clinical Physiology Associates/Clinical Study Center	Fort Myers	Florida
United States	Northway Medical Associates	Fulton	New York
United States	Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute	Gainesville	Florida
United States	Digestive and Liver Disease Specialists	Garden Grove	California
United States	RX Clinical Research, Inc	Garden Grove	California
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Medoff Medical/ Vital re:Search	Greensboro	North Carolina
United States	Comprehensive Pain Specialists, PLLC	Hendersonville	Tennessee
United States	Simon Williamson Clinic, PC	Hueytown	Alabama
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Physicians Clinical Research Corporation	Laguna Hills	California
United States	Impact Clinical Trials, Las Vegas	Las Vegas	Nevada
United States	Office of Stephen H. Miller, MD	Las Vegas	Nevada
United States	The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC	Lexington	Kentucky
United States	Loma Linda University Physicians Medical Group	Loma Linda	California
United States	HealthCare Partners Medical Group	Long Beach	California
United States	Impact Clinical Trials	Los Angeles	California
United States	The Regents of the University of California, Los Angeles	Los Angeles	California
United States	Drug Studies America	Marietta	Georgia
United States	Clinical Research Advantage, Inc./ Mesa Family Medical Center	Mesa	Arizona
United States	Clement J. Zablocki VA Medical Center	Milwaukee	Wisconsin
United States	Metro Physicians a Division of Wheaton Franciscan Medical Group	Milwaukee	Wisconsin
United States	Alabama Orthopedic Clinic	Mobile	Alabama
United States	Saltzer Medical Group	Nampa	Idaho
United States	Vanderbilt University - Interventional Pain Center	Nashville	Tennessee
United States	Advanced Diagnostic Pain Treatment Center	New Haven	Connecticut
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Trident Institute of Medical Research, LLC	North Charleston	South Carolina
United States	Permian Research Foundation	Odessa	Texas
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Pasadena Rehabilitation Institute	Pasadena	California
United States	Redhead Research Inc., dba Research Associates of Central Illinois	Peoria	Illinois
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Affinity Research	Portland	Oregon
United States	University Gastroenterology	Providence	Rhode Island
United States	Lynn Institute of Pueblo	Pueblo	Colorado
United States	University of Nevada	Reno	Nevada
United States	Bexar Clinical Trials, LLC	Richardson	Texas
United States	General Clinical Research Center, Virginia Commonwealth University, North Hospital	Richmond	Virginia
United States	International Research Clinicians of Conneticut	Ridgefield	Connecticut
United States	University of Rochester	Rochester	New York
United States	Northern California Research Corporation	Sacramento	California
United States	Salt Lake Research, PLLC	Salt Lake City	Utah
United States	Integrity Clinical Research, LLC	Savannah	Tennessee
United States	The Willis-Knighton Pain Management Center	Shreveport	Louisiana
United States	SB Family Medicine	Solana Beach	California
United States	Carolina Pharmaceutical Research	Statesville	North Carolina
United States	Pinnacle Trials Inc.	Stockbridge	Georgia
United States	UMDNJ	Stratford	New Jersey
United States	Clinical Research Advantage, Inc.	Tempe	Arizona
United States	New England Research Associates, LLC	Trumbull	Connecticut
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Harmony Clinical Research, Inc.	Tucson	Arizona
United States	Pusch Ridge Family Medicine / WC Clinical Research	Tucson	Arizona
United States	Quality of Life Medical & Research Center, LLC	Tucson	Arizona
United States	Verona Clinical Research, Inc.	Tucson	Arizona
United States	Digestive Health Specialists, PA	Tupelo	Mississippi
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Partners in Primary Care	Voorhees	New Jersey
United States	Abraham D. Morganoff, MD PA	Watchung	New Jersey
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Center for Clinical Research, LLC	Winston-Salem	North Carolina

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	Mean Weekly Spontaneous Bowel Movements at Week 8	Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.	at Week 8
Secondary	Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks	Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12	within 12 weeks
Secondary	Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose	The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.	within 48 hours post-dose
Secondary	Number of Participants Classified as Responders	Number of participants who remained on treatment for at least 8 weeks, and reported at least 3 SBMs for at least half the weeks on study.	within 12 weeks
Secondary	Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	Measures collected over 12-week treatment period were averaged, and the score at baseline was subtracted from the score at week 12 to determine the change from baseline.; Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) - middle scores are best; Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe - higher scores are worse; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular - higher scores are worse	within 12 weeks
Secondary	Participant Reported Outcome of Treatment Effectiveness	Participants rated treatment effectiveness at the end of each treatment week during the study on a 5-point scale, where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The 12 weekly scores were averaged. Higher scores mean the drug was more effective.	within 12 weeks