Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
12 janvier 2017 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
334
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35209
- Alabama Orthopaedic Center - Research
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Mobile, Alabama, États-Unis, 36608
- Coastal Clinical Research, Inc.
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Arizona
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Phoenix, Arizona, États-Unis, 85023
- Arizona Research Center
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California
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Fresno, California, États-Unis, 93710
- Neuro-Pain Medical Center
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La Jolla, California, États-Unis, 92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
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Long Beach, California, États-Unis, 90806
- Collaborative Neuroscience Network, Inc.
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Florida
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DeLand, Florida, États-Unis, 32720
- Avail Clinical Research, LLC
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Jupiter, Florida, États-Unis, 33458
- Health Awareness, Inc.
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Plantation, Florida, États-Unis, 33317
- Gold Coast Research, LLC
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Port Orange, Florida, États-Unis, 32129
- Accord Clinical Research, LLC
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Georgia
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Marietta, Georgia, États-Unis, 30060
- Taylor Research, LLC
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Illinois
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Bloomington, Illinois, États-Unis, 61701
- Millennium Pain Center
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Indiana
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Evansville, Indiana, États-Unis, 47714
- MediSphere Medical Research Center, LLC
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Kansas
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Leawood, Kansas, États-Unis, 66211
- International Clinical Research Institute
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Massachusetts
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Watertown, Massachusetts, États-Unis, 02472
- MedVadis Research Corporation
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Nevada
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Las Vegas, Nevada, États-Unis, 89144
- Office of Stephen H. Miller, MD
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New York
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New York, New York, États-Unis, 10022
- Research Across American
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North Carolina
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Raleigh, North Carolina, États-Unis, 27612
- Wake Research Associates, LLC
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Winston-Salem, North Carolina, États-Unis, 27103
- The Center for Clinical Research, LLC
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Pennsylvania
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Altoona, Pennsylvania, États-Unis, 16602
- Allegheny Pain Management
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Texas
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Austin, Texas, États-Unis, 78731
- FutureSearch Trials of Neurology
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El Paso, Texas, États-Unis, 79902
- Southwest Urgent Care Center
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Utah
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Salt Lake City, Utah, États-Unis, 84106
- Lifetree Clinical Research
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West Jordan, Utah, États-Unis, 84088
- Advanced Clinical Research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: BEMA Buprénorphine
film soluble buccal de buprénorphine
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buccal soluble film; applied to the buccal mucosa twice daily
Autres noms:
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Comparateur placebo: BEMA Placebo
placebo buccal soluble film
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buccal soluble film; applied to the buccal mucosa twice daily
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Pain Intensity From Baseline to Week 12
Délai: Baseline, Week 12
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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).
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Baseline, Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changement de la ligne de base à la semaine 12 dans le questionnaire sur le handicap de Roland Morris
Délai: Base de référence, semaine 12
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Les sujets évaluent l'invalidité due aux maux de dos à l'aide du questionnaire d'invalidité Roland Morris (RMDQ) composé de 24 déclarations d'invalidité.
Le score du RMDQ est le nombre total d'items cochés, allant de 0 à 24, les scores les plus élevés indiquant une plus grande incapacité.
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Base de référence, semaine 12
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
Délai: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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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).
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Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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Number of Participants With Response to Treatment as Assessed by an NRS Scale
Délai: Week 12
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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).
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Week 12
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Délai: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
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Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Délai: Baseline, Week 12
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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).
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Baseline, Week 12
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Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Délai: Baseline, Week 12
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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).
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Baseline, Week 12
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Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Délai: Baseline, Week 12
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Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
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Baseline, Week 12
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Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Délai: Baseline, Week 12
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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).
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Baseline, Week 12
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Use of Rescue Medication
Délai: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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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.
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Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2010
Achèvement primaire (Réel)
1 juillet 2011
Achèvement de l'étude (Réel)
1 juillet 2011
Dates d'inscription aux études
Première soumission
7 décembre 2010
Première soumission répondant aux critères de contrôle qualité
7 décembre 2010
Première publication (Estimation)
8 décembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 janvier 2017
Dernière vérification
1 janvier 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BUP-301
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .