Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
12 de enero de 2017 actualizado por: BioDelivery Sciences International
A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.
Tipo de estudio
Intervencionista
Inscripción (Actual)
334
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35209
- Alabama Orthopaedic Center - Research
-
Mobile, Alabama, Estados Unidos, 36608
- Coastal Clinical Research, Inc.
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85023
- Arizona Research Center
-
-
California
-
Fresno, California, Estados Unidos, 93710
- Neuro-Pain Medical Center
-
La Jolla, California, Estados Unidos, 92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
-
Long Beach, California, Estados Unidos, 90806
- Collaborative Neuroscience Network, Inc.
-
-
Florida
-
DeLand, Florida, Estados Unidos, 32720
- Avail Clinical Research, LLC
-
Jupiter, Florida, Estados Unidos, 33458
- Health Awareness, Inc.
-
Plantation, Florida, Estados Unidos, 33317
- Gold Coast Research, LLC
-
Port Orange, Florida, Estados Unidos, 32129
- Accord Clinical Research, LLC
-
-
Georgia
-
Marietta, Georgia, Estados Unidos, 30060
- Taylor Research, LLC
-
-
Illinois
-
Bloomington, Illinois, Estados Unidos, 61701
- Millennium Pain Center
-
-
Indiana
-
Evansville, Indiana, Estados Unidos, 47714
- MediSphere Medical Research Center, LLC
-
-
Kansas
-
Leawood, Kansas, Estados Unidos, 66211
- International Clinical Research Institute
-
-
Massachusetts
-
Watertown, Massachusetts, Estados Unidos, 02472
- MedVadis Research Corporation
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89144
- Office of Stephen H. Miller, MD
-
-
New York
-
New York, New York, Estados Unidos, 10022
- Research Across American
-
-
North Carolina
-
Raleigh, North Carolina, Estados Unidos, 27612
- Wake Research Associates, LLC
-
Winston-Salem, North Carolina, Estados Unidos, 27103
- The Center for Clinical Research, LLC
-
-
Pennsylvania
-
Altoona, Pennsylvania, Estados Unidos, 16602
- Allegheny Pain Management
-
-
Texas
-
Austin, Texas, Estados Unidos, 78731
- FutureSearch Trials of Neurology
-
El Paso, Texas, Estados Unidos, 79902
- Southwest Urgent Care Center
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84106
- Lifetree Clinical Research
-
West Jordan, Utah, Estados Unidos, 84088
- Advanced Clinical Research
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained at Screening, prior to any procedure being performed
Exclusion Criteria:
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
- Diagnosis of moderate to severe hepatic impairment.
- History of severe emesis with opioids
- Clinically significant sleep apnea
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: BEMA Buprenorfina
película soluble bucal de buprenorfina
|
buccal soluble film; applied to the buccal mucosa twice daily
Otros nombres:
|
|
Comparador de placebos: BEMA Placebo
placebo buccal soluble film
|
buccal soluble film; applied to the buccal mucosa twice daily
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Intensity From Baseline to Week 12
Periodo de tiempo: Baseline, Week 12
|
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization.
Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
Baseline, Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cambio desde el inicio hasta la semana 12 en el cuestionario de discapacidad de Roland Morris
Periodo de tiempo: Línea de base, semana 12
|
Los sujetos evalúan la discapacidad debido al dolor de espalda utilizando el Cuestionario de discapacidad de Roland Morris (RMDQ) que consta de 24 declaraciones de discapacidad.
El puntaje del RMDQ es el número total de elementos verificados, que van de 0 a 24, donde los puntajes más altos indican una mayor discapacidad.
|
Línea de base, semana 12
|
|
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Periodo de tiempo: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
|
Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization.
Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
|
|
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Periodo de tiempo: Week 12
|
Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
|
Week 12
|
|
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Periodo de tiempo: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
|
Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
|
Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
|
|
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Periodo de tiempo: Baseline, Week 12
|
Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
|
Baseline, Week 12
|
|
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Periodo de tiempo: Baseline, Week 12
|
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction.
Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
|
Baseline, Week 12
|
|
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Periodo de tiempo: Baseline, Week 12
|
Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
|
Baseline, Week 12
|
|
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Periodo de tiempo: Baseline, Week 12
|
Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
|
Baseline, Week 12
|
|
Use of Rescue Medication
Periodo de tiempo: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
|
Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
|
Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de julio de 2011
Finalización del estudio (Actual)
1 de julio de 2011
Fechas de registro del estudio
Enviado por primera vez
7 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
7 de diciembre de 2010
Publicado por primera vez (Estimar)
8 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2017
Última verificación
1 de enero de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BUP-301
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. .