- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00595946
Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone (OPAL)
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- Health Sciences Center
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Alabama
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Birmingham, Alabama, Estados Unidos, 35242
- The Birmingham Pain Center
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Hueytown, Alabama, Estados Unidos, 35023
- Simon Williamson Clinic, PC
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Mobile, Alabama, Estados Unidos, 36608
- Alabama Orthopedic Clinic
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Arizona
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Mesa, Arizona, Estados Unidos, 85203
- Clinical Research Advantage, Inc./ Mesa Family Medical Center
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Tempe, Arizona, Estados Unidos, 85282
- Clinical Research Advantage, Inc.
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Tucson, Arizona, Estados Unidos, 85712
- Quality of Life Medical & Research Center, LLC
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Tucson, Arizona, Estados Unidos, 85741
- Genova Clinical Research, Inc.
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Tucson, Arizona, Estados Unidos, 85705
- Harmony Clinical Research, Inc.
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Tucson, Arizona, Estados Unidos, 85710-3539
- Verona Clinical Research, Inc.
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Tucson, Arizona, Estados Unidos, 85741
- Pusch Ridge Family Medicine / WC Clinical Research
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California
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Anaheim, California, Estados Unidos, 92801
- Advanced Clinical Research Institute
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Anaheim, California, Estados Unidos, 92801
- Orange County Clinical Trials, Inc.
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Chula Vista, California, Estados Unidos, 91910
- Gregory J. Wiener, MD PC
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Garden Grove, California, Estados Unidos, 92840
- Digestive and Liver Disease Specialists
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Garden Grove, California, Estados Unidos, 92843
- RX Clinical Research, Inc
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Laguna Hills, California, Estados Unidos, 92653
- Physicians Clinical Research Corporation
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Physicians Medical Group
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Long Beach, California, Estados Unidos, 90807
- HealthCare Partners Medical Group
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Los Angeles, California, Estados Unidos, 90036
- Impact Clinical Trials
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Los Angeles, California, Estados Unidos, 90095
- The Regents of the University of California, Los Angeles
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Pasadena, California, Estados Unidos, 91105
- Pasadena Rehabilitation Institute
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Sacramento, California, Estados Unidos, 95831
- Northern California Research Corporation
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Solana Beach, California, Estados Unidos, 92075
- SB Family Medicine
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909
- Lynn Institute Of The Rockies
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Pueblo, Colorado, Estados Unidos, 81001
- Lynn Institute of Pueblo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Advanced Diagnostic Pain Treatment Center
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Ridgefield, Connecticut, Estados Unidos, 06877
- International Research Clinicians of Conneticut
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Trumbull, Connecticut, Estados Unidos, 06611
- New England Research Associates, LLC
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Florida
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Brooksville, Florida, Estados Unidos, 34613
- Meridien Research
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Clermont, Florida, Estados Unidos, 34711
- South Lake Pain Institute
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Daytona Beach, Florida, Estados Unidos, 32117
- International Medical Research
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Daytona Beach, Florida, Estados Unidos, 32117
- Century Clinical Research
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Fort Myers, Florida, Estados Unidos, 33916
- Clinical Physiology Associates/Clinical Study Center
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Gainesville, Florida, Estados Unidos, 32607
- Southeaster Integrated Medical, PL d/b/a Florida Medical Research Institute
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West Palm Beach, Florida, Estados Unidos, 33409
- Palm Beach Research Center
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Georgia
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Dawsonville, Georgia, Estados Unidos, 30534
- North Georgia Premier Research
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Decatur, Georgia, Estados Unidos, 30034
- Best Clinical Research
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Marietta, Georgia, Estados Unidos, 30060
- Drug Studies America
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Stockbridge, Georgia, Estados Unidos, 30281
- Pinnacle Trials Inc.
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Rosemark Women Care Specialists
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Nampa, Idaho, Estados Unidos, 83686
- Saltzer Medical Group
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Illinois
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Bloomington, Illinois, Estados Unidos, 61701
- Millenium Pain Center
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Medical Center
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Peoria, Illinois, Estados Unidos, 61614
- Redhead Research Inc., dba Research Associates of Central Illinois
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Iowa
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West Des Moines, Iowa, Estados Unidos, 50265
- Integrated Clinical Trial Services, Inc.
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- The Pain Treatment Center of the Bluegrass and Ballard Wright, MD PSC
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Gulf Coast Research, LLC
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University Health Sciences Center
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Shreveport, Louisiana, Estados Unidos, 71103
- The Willis-Knighton Pain Management Center
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Maryland
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Bethesda, Maryland, Estados Unidos, 20814
- Pain and Rehabilitation Medicine
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- The Brigham and Women's Hospital
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Michigan
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Benzonia, Michigan, Estados Unidos, 49616
- Professional Clinical Research, Benzonia
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Dearborn, Michigan, Estados Unidos, 48124
- Center for Clinical Studies
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Flint, Michigan, Estados Unidos, 48504
- Apex Medical Research, AMR, Inc.
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Mississippi
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Tupelo, Mississippi, Estados Unidos, 38801
- Digestive Health Specialists, PA
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Impact Clinical Trials, Las Vegas
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Las Vegas, Nevada, Estados Unidos, 89106
- Office of Stephen H. Miller, MD
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Reno, Nevada, Estados Unidos, 89557
- University of Nevada
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper Health System
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Stratford, New Jersey, Estados Unidos, 08084
- UMDNJ
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Voorhees, New Jersey, Estados Unidos, 08043
- Partners in Primary Care
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Watchung, New Jersey, Estados Unidos, 07069
- Abraham D. Morganoff, MD PA
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New York
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Fulton, New York, Estados Unidos, 13069
- Northway Medical Associates
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Great Neck, New York, Estados Unidos, 11021
- Long Island Clinical Research Associates, LLP
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Great Neck, New York, Estados Unidos, 11023
- Long Island Gastrointestinal Research Group
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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North Carolina
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Durham, North Carolina, Estados Unidos, 27704
- Diversified Research
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Greensboro, North Carolina, Estados Unidos, 27408
- Medoff Medical/ Vital re:Search
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Statesville, North Carolina, Estados Unidos, 28625
- Carolina Pharmaceutical Research
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Center for Clinical Research, LLC
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- St. Alexius Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- COR Clinical Research, LLC
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Pain Research of Oregon, LLC
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Portland, Oregon, Estados Unidos, 97219
- Affinity Research
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18104
- Private Practice of Dr. Hasan
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Uniontown, Pennsylvania, Estados Unidos, 15401
- Preferred Primary Care Physicians
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Rhode Island
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Cumberland, Rhode Island, Estados Unidos, 02864
- Partners in Clinical Research
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Providence, Rhode Island, Estados Unidos, 02905
- University Gastroenterology
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South Carolina
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North Charleston, South Carolina, Estados Unidos, 29406
- Trident Institute of Medical Research, LLC
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- Southeastern Clinical Research
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Hendersonville, Tennessee, Estados Unidos, 37075
- Comprehensive Pain Specialists, PLLC
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University - Interventional Pain Center
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Savannah, Tennessee, Estados Unidos, 38372
- Integrity Clinical Research, LLC
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Texas
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Dallas, Texas, Estados Unidos, 75216
- Dallas VA Research Corporation, Inc.
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Dallas, Texas, Estados Unidos, 75234
- Bexar Clinical Trials, LLC
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Odessa, Texas, Estados Unidos, 79761
- Permian Research Foundation
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Richardson, Texas, Estados Unidos, 75082
- Bexar Clinical Trials, LLC
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Salt Lake Research, PLLC
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Digestive and Liver Disease Specialists
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Richmond, Virginia, Estados Unidos, 23298
- General Clinical Research Center, Virginia Commonwealth University, North Hospital
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53295
- Clement J. Zablocki VA Medical Center
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Milwaukee, Wisconsin, Estados Unidos, 53221
- Metro Physicians a Division of Wheaton Franciscan Medical Group
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Lubiprostona
Cápsulas de 24 mcg dos veces al día (BID)
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Cápsulas de 24 mcg dos veces al día (BID)
Otros nombres:
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Comparador de placebos: Placebo
0 mcg cápsulas dos veces al día (BID)
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0 mcg cápsulas dos veces al día (BID)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Weekly Spontaneous Bowel Movements at Week 8
Periodo de tiempo: at Week 8
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Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.
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at Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks
Periodo de tiempo: within 12 weeks
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Average weekly SBM frequency was calculated from data collected from Week 1 through Week 12
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within 12 weeks
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Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose
Periodo de tiempo: within 48 hours post-dose
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The number of participants who experienced their first post-dose Spontaneous Bowel Movement within 24 and 48 hours after dosing started.
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within 48 hours post-dose
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Number of Participants Classified as Responders
Periodo de tiempo: within 12 weeks
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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.
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within 12 weeks
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Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity
Periodo de tiempo: within 12 weeks
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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
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Participant Reported Outcome of Treatment Effectiveness
Periodo de tiempo: within 12 weeks
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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.
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within 12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Enfermedades del Sistema Digestivo
- Trastornos relacionados con sustancias
- Signos y Síntomas Digestivos
- Trastornos relacionados con narcóticos
- Estreñimiento
- Enfermedades Gastrointestinales
- Enfermedades intestinales
- Estreñimiento inducido por opioides
- Mecanismos moleculares de acción farmacológica
- Moduladores de transporte de membrana
- Agonistas de los canales de cloruro
- Lubiprostona
Otros números de identificación del estudio
- OBD0631
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .