Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
12. januar 2017 oppdatert 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
334
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35209
- Alabama Orthopaedic Center - Research
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Mobile, Alabama, Forente stater, 36608
- Coastal Clinical Research, Inc.
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Arizona
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Phoenix, Arizona, Forente stater, 85023
- Arizona Research Center
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California
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Fresno, California, Forente stater, 93710
- Neuro-Pain Medical Center
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La Jolla, California, Forente stater, 92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
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Long Beach, California, Forente stater, 90806
- Collaborative Neuroscience Network, Inc.
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Florida
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DeLand, Florida, Forente stater, 32720
- Avail Clinical Research, LLC
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Jupiter, Florida, Forente stater, 33458
- Health Awareness, Inc.
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Plantation, Florida, Forente stater, 33317
- Gold Coast Research, LLC
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Port Orange, Florida, Forente stater, 32129
- Accord Clinical Research, LLC
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Georgia
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Marietta, Georgia, Forente stater, 30060
- Taylor Research, LLC
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Illinois
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Bloomington, Illinois, Forente stater, 61701
- Millennium Pain Center
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Indiana
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Evansville, Indiana, Forente stater, 47714
- MediSphere Medical Research Center, LLC
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Kansas
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Leawood, Kansas, Forente stater, 66211
- International Clinical Research Institute
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Massachusetts
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Watertown, Massachusetts, Forente stater, 02472
- MedVadis Research Corporation
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Nevada
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Las Vegas, Nevada, Forente stater, 89144
- Office of Stephen H. Miller, MD
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New York
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New York, New York, Forente stater, 10022
- Research Across American
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North Carolina
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Raleigh, North Carolina, Forente stater, 27612
- Wake Research Associates, LLC
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Winston-Salem, North Carolina, Forente stater, 27103
- The Center for Clinical Research, LLC
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Pennsylvania
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Altoona, Pennsylvania, Forente stater, 16602
- Allegheny Pain Management
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Texas
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Austin, Texas, Forente stater, 78731
- FutureSearch Trials of Neurology
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El Paso, Texas, Forente stater, 79902
- Southwest Urgent Care Center
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Utah
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Salt Lake City, Utah, Forente stater, 84106
- Lifetree Clinical Research
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West Jordan, Utah, Forente stater, 84088
- Advanced Clinical Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: BEMA buprenorfin
buprenorfin bukkal oppløselig film
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buccal soluble film; applied to the buccal mucosa twice daily
Andre navn:
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Placebo komparator: BEMA Placebo
placebo buccal soluble film
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buccal soluble film; applied to the buccal mucosa twice daily
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pain Intensity From Baseline to Week 12
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endre fra baseline til uke 12 i Roland Morris Disability Questionnaire
Tidsramme: Baseline, uke 12
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Forsøkspersonene vurderer funksjonshemming på grunn av ryggsmerter ved å bruke Roland Morris Disability Questionnaire (RMDQ) som består av 24 uttalelser om funksjonshemming.
Poengsummen til RMDQ er det totale antallet kontrollerte elementer, fra 0 til 24 med høyere poengsum som indikerer større funksjonshemming.
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Baseline, uke 12
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. juli 2011
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
7. desember 2010
Først innsendt som oppfylte QC-kriteriene
7. desember 2010
Først lagt ut (Anslag)
8. desember 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BUP-301
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .