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Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

Information source: Sucampo Pharma Americas, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-Induced Bowel Dysfunction

Intervention: Lubiprostone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sucampo Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Egilius L.H. Spierings, M.D., Ph.D., Principal Investigator, Affiliation: MedVadis Research Corporation

Summary

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with OBD.

Clinical Details

Official title: A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in SBM frequency

Secondary outcome:

Change from baseline in SBM frequency

First post-dose SBM (percentage of patients)

Responder rate

Mean changes from baseline in straining, stool consistency, constipation severity, abdominal bloating, abdominal discomfort, and bowel habit regularity

Treatment effectiveness

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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 OTC medication that affects gastrointestinal motility (other

than opioid therapy) must be discontinued during the study.

- If treated for clinical depression with SSRIs, SNRIs, or 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.

- Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

- 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.

Locations and Contacts

Tuscaloosa VA Medical Center, Tuscaloosa, Alabama 35404, United States

Hermitage Medicentre, Edmonton, Alberta T5A 4L8, Canada

Carl T Hayden VA Medical Center, Phoenix, Arizona 85012, United States

HOPE Research Institute, LLC, Phoenix, Arizona 85050, United States

Redpoint Research, Phoenix, Arizona 85029, United States

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC, Tempe, Arizona 85222, United States

Premiere Pharamaceutical Research, LLC, Tempe, Arizona 85282, United States

Harmony Clinical Research, Inc., Tucson, Arizona 85705, United States

Martin Bowen Hefley Knee, Little Rock, Arkansas 72205, United States

Advanced Pain Institute, Arcadia, California 91007, United States

Pain Institute of CA, Bakersfield, California 93311, United States

Catalina Research Institute, LLC, Chino, California 91710, United States

California Pain Center, Huntington Beach, California 92647, United States

Shreenath Clinical Service, Laguna Hills, California 92637, United States

Loma Linda University Physicians Medical Group, Loma Linda, California 92354, United States

VA Long Beach Healthcare System, Long Beach, California 90822-5201, United States

Rider Research Group, San Francisco, California 94117, United States

Clinicos, LLC, Colorado Springs, Colorado 80904, United States

Rocky Mountain Gastroenterology Associates, Lakewood, Colorado 80215, United States

Arapahoe Gastroenterology, PC, Littleton, Colorado 80120, United States

Metro Clinical Research, LLC, Littleton, Colorado 80122, United States

Clinical Trial Management of Boca Raton, Inc., Boca Raton, Florida 33486, United States

Florida Institute of Medical Research, Jacksonville, Florida 32257, United States

Drug Study Institute, Jupiter, Florida 33458, United States

Gastroenterology Group of Naples, Naples, Florida 34102, United States

Kenneth W. Ponder, MD PA, Niceville, Florida 32578, United States

North Miami Research, Inc., North Miami, Florida 33161, United States

Renstar Inc., Ocala, Florida 34471, United States

Peninsula Research, Inc, Ormond Beach, Florida 32174, United States

DMI Research, Inc., Pinellas Park, Florida 33782, United States

Sunrise Medical Research, Inc., Plantation, Florida 33324, United States

Accord Clinical Research, LLC, Port Orange, Florida 32129, United States

Lovelace Scientific Resources, Inc., Sarasota, Florida 34233, United States

Meridien Research, St. Petersburg, Florida 33709, United States

Clinical Research of West Florida, Inc., Tampa, Florida 33603, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Advanced Pain Management, Augusta, Georgia 30901, United States

Global Research Partners & Consultants, Incs., Calhoun, Georgia 30701, United States

Q Clinical Research, Decatur, Georgia 30035, United States

Apex Medical Research, AMR, Inc., Chicago, Illinois 60616, United States

Claude Mandel Medical Center, Chicago, Illinois 60617, United States

Advanced Pain Care Clinic, Evansville, Indiana 47630, United States

MediSphere Medical Research Center, Evansville, Indiana 47714, United States

Davis Clinic, PC, Indianapolis, Indiana 46260, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

University of Louisville, Louisville, Kentucky 40202, United States

Gulf Coast Research, LLC, Lafayette, Louisiana 70503, United States

Delta Research Partners, LLC, Monroe, Louisiana 71201, United States

Louisiana Research Center, LLC, Shreveport, Louisiana 71103, United States

Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada

Rehabilitation Team West, PA, Baltimore, Maryland 21228, United States

Columbia Medical Practice/ RxTrials, Inc., Columbia, Maryland 21045, United States

Washington County Hospital Association - The Center for Clinical Research, Hagerstown, Maryland 21742, United States

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts 02215, United States

MedVadis Research Corporation, Wellesley Hills, Massachusetts 02481, United States

Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan 48047, United States

Professional Clinical Research, Inc., Interlochen, Michigan 49643, United States

PCM Medical Services, Lansing, Michigan 48917, United States

Women's Health Care Specialists, PC, Paw Paw, Michigan 49079, United States

Medical Research Associates, Traverse City, Michigan 49684, United States

Center for Digestive Health, Troy, Michigan 48098, United States

MAPS Applied Research Center, Edina, Minnesota 55435, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Precise Research, Inc., Flowood, Mississippi 39232, United States

Medex Healthcare Research, St. Louis, Missouri 63117, United States

Montana Neuroscience Institute Foundation / Montana Spine and Pain Center, Missoula, Montana 59802, United States

Creighton University Medical Center, Omaha, Nebraska 68131, United States

Advanced Biomedical Research of America, Las Vegas, Nevada 89123, United States

Lovelace Scientific Resources, Inc., Las Vegas, Nevada 89146, United States

Gastroenterology Research Associates, Cedar Knolls, New Jersey 07927, United States

Central Jersey Medical Research Center, Elizabeth, New Jersey 07202, United States

Holy Name Hospital, Institute for Clinical Research, Teaneck, New Jersey 07666, United States

Advanced Pain Consultants, Voorhees, New Jersey 08043, United States

Medex Healthcare Research, Inc., New York, New York 10004, United States

New York University Pain Management Center, New York, New York 10016, United States

Research Across America, New York, New York 10022, United States

North American Partners, Valley Stream, New York 11580, United States

Upstate Clinical Research Associates, Williamsville, New York 14221, United States

Randolph Medical Associates, Asheboro, North Carolina 27203, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Carolina Research, Greenville, North Carolina 27834, United States

Carolina Digestive Health Associates, Harrisburg, North Carolina 28075, United States

Peters Medical Research, LLC, High Point, North Carolina 27262, United States

Triangle Medical Research, Lexington, North Carolina 27295, United States

Southern Gastroenterology Associates, New Bern, North Carolina 28562, United States

Valley Medical Primary Care, Centerville, Ohio 45459, United States

Glenway Family Medicine, Cincinnati, Ohio 45238, United States

The Ohio State University Medical Center, Columbus, Ohio 43210-1228, United States

Urgent Care Specialists, Dayton, Ohio 45432, United States

RAS Health Ltd., Marion, Ohio 43302, United States

University of Toledo - Health Science Campus, Toledo, Ohio 43614, United States

Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Memorial Clinical Research, Oklahoma City, Oklahoma 73134, United States

Paradigm Research Professionals, LLP, Oklahoma City, Oklahoma 73112, United States

St. Joseph's Healthcare Hamilton, Hamilton, Ontario L8N 4A6, Canada

Pharmaceutical Integrated Research Company, London, Ontario N5X4E7, Canada

DHC Research, Richmond Hill, Ontario L4B 3P8, Canada

Medford Medical Clinic, LLP, Medford, Oregon 97504, United States

Lehigh Valley Hospital - Neurosciences and Pain Research, Allentown, Pennsylvania 18103, United States

Einstein Pain Institute, Philadelphia, Pennsylvania 19414, United States

Jeffry A. Lindenbaum DO, PC, Yardley, Pennsylvania 19067, United States

Baptist Medical Tower Suite 740, Knoxville, Tennessee 37920, United States

Integrity Clinical Research, LLC, Milan, Tennessee 38358, United States

Texas Familicare Clinical Research, Hurst, Texas 76054, United States

DCOL Center for Clinical Research, Longview, Texas 75605, United States

Bexar Clinical Trials, LLC, Richardson, Texas 75082, United States

Advance Research Institute, Ogden, Utah 84405, United States

Highland Clinical Research, Salt Lake City, Utah 84124, United States

University of Utah, Salt Lake City, Utah 84132-2410, United States

New River Valley Research Institute, Christianburg, Virginia 24073, United States

Hampton Roads Institute for Performance and Sports Medicine (HIPS), Portsmouth, Virginia 23707, United States

McGuire Research Institute, Richmond, Virginia 23249, United States

Northwest Gastroenterology Associates, Bellevue, Washington 98004, United States

Daniel R. Coulston, Spokane, Washington 99204, United States

Additional Information

Starting date: August 2007
Last updated: February 1, 2013

Page last updated: August 23, 2015

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