Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
12 januari 2017 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
334
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35209
- Alabama Orthopaedic Center - Research
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Mobile, Alabama, Förenta staterna, 36608
- Coastal Clinical Research, Inc.
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Arizona
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Phoenix, Arizona, Förenta staterna, 85023
- Arizona Research Center
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California
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Fresno, California, Förenta staterna, 93710
- Neuro-Pain Medical Center
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La Jolla, California, Förenta staterna, 92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
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Long Beach, California, Förenta staterna, 90806
- Collaborative Neuroscience Network, Inc.
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Florida
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DeLand, Florida, Förenta staterna, 32720
- Avail Clinical Research, LLC
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Jupiter, Florida, Förenta staterna, 33458
- Health Awareness, Inc.
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Plantation, Florida, Förenta staterna, 33317
- Gold Coast Research, LLC
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Port Orange, Florida, Förenta staterna, 32129
- Accord Clinical Research, LLC
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Georgia
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Marietta, Georgia, Förenta staterna, 30060
- Taylor Research, LLC
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Illinois
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Bloomington, Illinois, Förenta staterna, 61701
- Millennium Pain Center
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Indiana
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Evansville, Indiana, Förenta staterna, 47714
- MediSphere Medical Research Center, LLC
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Kansas
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Leawood, Kansas, Förenta staterna, 66211
- International Clinical Research Institute
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Massachusetts
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Watertown, Massachusetts, Förenta staterna, 02472
- MedVadis Research Corporation
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89144
- Office of Stephen H. Miller, MD
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-
New York
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New York, New York, Förenta staterna, 10022
- Research Across American
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27612
- Wake Research Associates, LLC
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Winston-Salem, North Carolina, Förenta staterna, 27103
- The Center for Clinical Research, LLC
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Pennsylvania
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Altoona, Pennsylvania, Förenta staterna, 16602
- Allegheny Pain Management
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Texas
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Austin, Texas, Förenta staterna, 78731
- FutureSearch Trials of Neurology
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El Paso, Texas, Förenta staterna, 79902
- Southwest Urgent Care Center
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Utah
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Salt Lake City, Utah, Förenta staterna, 84106
- Lifetree Clinical Research
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West Jordan, Utah, Förenta staterna, 84088
- Advanced Clinical Research
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: BEMA buprenorfin
buprenorfin buckal löslig film
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buccal soluble film; applied to the buccal mucosa twice daily
Andra namn:
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Placebo-jämförare: BEMA Placebo
placebo buccal soluble film
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buccal soluble film; applied to the buccal mucosa twice daily
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Pain Intensity From Baseline to Week 12
Tidsram: 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).
|
Baseline, Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Ändra från baslinje till vecka 12 i Roland Morris Disability Questionnaire
Tidsram: Baslinje, vecka 12
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Försökspersoner bedömer funktionshinder på grund av ryggsmärta med hjälp av Roland Morris Disability Questionnaire (RMDQ) som består av 24 uttalanden om funktionshinder.
Poängen för RMDQ är det totala antalet föremål som kontrolleras, från 0 till 24 med högre poäng som indikerar större funktionshinder.
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Baslinje, vecka 12
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2010
Primärt slutförande (Faktisk)
1 juli 2011
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
7 december 2010
Först inskickad som uppfyllde QC-kriterierna
7 december 2010
Första postat (Uppskatta)
8 december 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BUP-301
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .