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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00620061
Other study ID # OBD06S1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2007
Est. completion date September 2009

Study information

Verified date March 2018
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.


Recruitment information / eligibility

Status Completed
Enrollment 439
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428

- Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study

- Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria:

- Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]

- Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.

- Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Study Design


Intervention

Drug:
Lubiprostone 24
24 mcg capsules for oral administration

Locations

Country Name City State
Canada AIM Health Group London North London Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Health Sciences Centre Pain Clinic Winnipeg Manitoba
United States Lehigh Gastroenterology Associates Allentown Pennsylvania
United States Advanced Clinical Research Institute Anaheim California
United States Orange County Clinical Trials Anaheim California
United States Advanced Pain Institute Arcadia California
United States Pinnacle Trials Inc. Atlanta Georgia
United States Northwest Gastroenterology Associates Bellevue Washington
United States Pain and Rehabilitation Medicine Bethesda Maryland
United States Impact Clinical Trials Beverly Hills California
United States The Birmingham Pain Center Birmingham Alabama
United States Millenium Pain Center Bloomington Illinois
United States Meridien Research Brooksville Florida
United States Gastroenterology Research Associates, LLC Cedar Knolls New Jersey
United States Southeastern Clinical Research Chattanooga Tennessee
United States Brigham and Women's Hosptial Chestnut Hill Massachusetts
United States Apex Medical Research, AMR, Inc Chicago Illinois
United States University of Illinois at Chicago: Department of Medicine Chicago Illinois
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 Lynn Institute of the Rockies Colorado Springs Colorado
United States Columbia Medical Practice/ RxTrials, Inc. Columbia Maryland
United States The Ohio State University Medical Center Columbus Ohio
United States North Georgia Premier Research Dawsonville Georgia
United States Hometown Urgent Care and Research Dayton Ohio
United States Century Clinical Research Inc 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 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 Pain Research of Oregon, LLC Eugene Oregon
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States Apex Medical Research, AMR, Inc. Flint Michigan
United States Clinical Physiology Associates/Clinical Study Center Fort Myers Florida
United States Southeastern Integrated Medical, PL dba Florida 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 Gastrointestinal Research Group Great Neck New York
United States Carolina Research Greenville North Carolina
United States Comprehensive Pain Specialists, PLLC Hendersonville Tennessee
United States Peters Medical Research, LLC High Point North Carolina
United States Century Clinical Research Holly Hill Florida
United States Arkansas Pain Research Hot Springs Arkansas
United States Simon Williamson Clinic, PC Hueytown Alabama
United States Texas Familicare Clinical Research Hurst Texas
United States Davis Clinic, PC Indianapolis Indiana
United States Professional Clinical Research - Interlochen Interlochen Michigan
United States Florida Institute of Medical Research Jacksonville Florida
United States Drug Study Institute Jupiter Florida
United States Beyer Research Kalamazoo Michigan
United States Affiliated Clinical Research, Inc. Las Vegas Nevada
United States Impact Clinical Trials Las Vegas Nevada
United States Ladder Family Practice Las Vegas Nevada
United States Office of Stephen H. Miller, MD Las Vegas Nevada
United States Sunrise Medical Research, Inc. Lauderdale Lakes Florida
United States The Pain Treatment Center of the Bluegrass Lexington Kentucky
United States Teton Research, LLC Little Rock Arkansas
United States Loma Linda University Loma Linda California
United States DCOL Center for Clinical Research Longview Texas
United States Virtua Lumberton Family Physicians Lumberton New Jersey
United States Drug Studies America Marietta Georgia
United States RAS Health Ltd. Marion Ohio
United States Medford Medical Clinic, LLP Medford Oregon
United States Clinical Research Advantage, Inc./ Mesa Family Medical Center Mesa Arizona
United States Integrity Clinical Research, LLC Milan Tennessee
United States VAMC Milwaukee Milwaukee Wisconsin
United States Montana Neuroscience Institute Foundation / Montana Spine and Pain Center Missoula Montana
United States Alabama Orthopedic Clinic Mobile Alabama
United States Advanced Diagnostic Pain Treatment Center New Haven Connecticut
United States NYU 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 Digestive and Liver Disease Specialists Norfolk Virginia
United States Trident Institute of Medical Research, LLC North Charleston South Carolina
United States North Miami Research Inc. North Miami Florida
United States Advanced Research Institute Ogden Utah
United States COR Clinical Research, LLC Oklahoma City Oklahoma
United States McBride Clinic Oklahoma City Oklahoma
United States Memorial Clinical Research Oklahoma City Oklahoma
United States Pasadena Rehabilitation Institute Pasadena California
United States Redhead Research Inc. Peoria Illinois
United States Albert Einstein Healthcare Network Einstein Pain Institute Philadelphia Pennsylvania
United States Clinical Research Advantage, Inc. Phoenix Arizona
United States HOPE Research Institute Phoenix Arizona
United States Redpoint Research Phoenix Arizona
United States DMI Health Care Group, Inc. Pinellas Park Florida
United States Accord Clinical Research, LLC Port Orange Florida
United States Affinity Research Portland Oregon
United States Hampton Roads Institution for Performance and Sports Medicine Portsmouth Virginia
United States McGuire VA Medical Center Richmond Virginia
United States University of Rochester, Pain Treatment Center Rochester New York
United States Northern California Research Corporation Sacramento California
United States Medex Healthcare Research Inc. Saint Louis Missouri
United States Meridien Research Saint Petersburg Florida
United States Highland Clinical Research Salt Lake City Utah
United States Rider Research Group San Francisco California
United States Louisiana Research Center, LLC Shreveport Louisiana
United States The Willis-Knighton Interventional Pain Center Shreveport Louisiana
United States Clinical Research of West Florida, Inc. Tampa Florida
United States Stedman Clinical Trials Tampa Florida
United States Holy Name Hospital Teaneck New Jersey
United States Clinical Research Advantage, Inc. Tempe Arizona
United States Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC Tempe Arizona
United States Premiere Pharamaceutical Research, LLC Tempe Arizona
United States Medical Research Associates Traverse City Michigan
United States Center for Digestive Health Troy Michigan
United States Advanced Clinical Therapeutics, LLC Tucson Arizona
United States Genova Clinical Research Tucson Arizona
United States Paradigm Clinical Research, Inc. Tucson Arizona
United States Quality of Life Medical & Research Center, LLC Tucson Arizona
United States Verona Clinical Research, Inc. Tucson Arizona
United States Wilson and Charani Tucson Arizona
United States MedVadis Research Corporation Wellesley Hills Massachusetts
United States Intergrated Clinical Trial Services, Inc West Des Moines Iowa
United States Palm Beach Research Center West Palm Beach Florida
United States Upstate Clinical Research Associates Williamsville New York
United States The Center for Clinical Research Winston-Salem North Carolina
United States Jeffry A. Lindenbaum DO, PC Yardley Pennsylvania
United States ShahShreenath Clinical Service Yorba Linda California

Sponsors (1)

Lead Sponsor Collaborator
Sucampo Pharma Americas, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Primary Mean Weekly Bowel Movements (BMs) Per Month A Bowel Movement (BM) is defined as any BM (whether spontaneous or not) Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Number of Participants Classified as Monthly Responders A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed).
A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Straining Associated With Spontaneous Bowel Movements by Month Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better. Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Stool Consistency of Spontaneous Bowel Movements by Month Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2. Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Constipation Severity by Month Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Abdominal Bloating by Month Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Abdominal Discomfort by Month Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The highest score is 4, but the best score is 0.
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Bowel Habit Regularity by Month Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular.
The highest score is 7, but the best score is 1.
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Treatment Effectiveness by Month Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.
The highest and best score is 4.
Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Mean Weekly Complete SBMs by Month Participants rate each SBM as complete if their bowels feel completely empty after the SBM Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary Mean Weekly Complete BMs by Month Participants rate each BM as complete if their bowels feel completely empty after the BM Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
See also
  Status Clinical Trial Phase
Recruiting NCT06334198 - The Effect of Naldemedine on Opioid-induced Bowel Dysfunction Phase 2
Completed NCT01298219 - Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL) Phase 3
Completed NCT00597428 - Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone Phase 3
Completed NCT00595946 - Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone Phase 3
Completed NCT06385561 - The Influence of Tramadol on Opioid-induced Bowel Dysfunction Phase 2
Recruiting NCT04876508 - The Efficacy of Acupressure in Managing Opioid-induced Constipation N/A