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Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

2017년 1월 12일 업데이트: 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).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

334

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35209
        • Alabama Orthopaedic Center - Research
      • Mobile, Alabama, 미국, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Phoenix, Arizona, 미국, 85023
        • Arizona Research Center
    • California
      • Fresno, California, 미국, 93710
        • Neuro-Pain Medical Center
      • La Jolla, California, 미국, 92037
        • University of California, San Diego Medical Center, UCSD Center for Pain Medicine
      • Long Beach, California, 미국, 90806
        • Collaborative Neuroscience Network, Inc.
    • Florida
      • DeLand, Florida, 미국, 32720
        • Avail Clinical Research, LLC
      • Jupiter, Florida, 미국, 33458
        • Health Awareness, Inc.
      • Plantation, Florida, 미국, 33317
        • Gold Coast Research, LLC
      • Port Orange, Florida, 미국, 32129
        • Accord Clinical Research, LLC
    • Georgia
      • Marietta, Georgia, 미국, 30060
        • Taylor Research, LLC
    • Illinois
      • Bloomington, Illinois, 미국, 61701
        • Millennium Pain Center
    • Indiana
      • Evansville, Indiana, 미국, 47714
        • MediSphere Medical Research Center, LLC
    • Kansas
      • Leawood, Kansas, 미국, 66211
        • International Clinical Research Institute
    • Massachusetts
      • Watertown, Massachusetts, 미국, 02472
        • MedVadis Research Corporation
    • Nevada
      • Las Vegas, Nevada, 미국, 89144
        • Office of Stephen H. Miller, MD
    • New York
      • New York, New York, 미국, 10022
        • Research Across American
    • North Carolina
      • Raleigh, North Carolina, 미국, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, 미국, 27103
        • The Center for Clinical Research, LLC
    • Pennsylvania
      • Altoona, Pennsylvania, 미국, 16602
        • Allegheny Pain Management
    • Texas
      • Austin, Texas, 미국, 78731
        • FutureSearch Trials of Neurology
      • El Paso, Texas, 미국, 79902
        • Southwest Urgent Care Center
    • Utah
      • Salt Lake City, Utah, 미국, 84106
        • Lifetree Clinical Research
      • West Jordan, Utah, 미국, 84088
        • Advanced Clinical Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: BEMA 부프레노르핀
부프레노르핀 협측 가용성 필름
의약품: Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
다른 이름들:
  • BEMA 부프레노르핀
  • 벨부카
  • 부프레노르핀 협측 가용성 필름
  • buprenorphine HCl buccal film
위약 비교기: BEMA Placebo
placebo buccal soluble film
의약품: Placebo
buccal soluble film; applied to the buccal mucosa twice daily
다른 이름들:
  • 위약 협측 필름
  • BEMA 위약
  • Placebo buccal soluble film

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Pain Intensity From Baseline to Week 12
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Roland Morris 장애 설문지의 기준선에서 12주차로 변경
기간: 기준선, 12주차
피험자는 24개의 장애 진술로 구성된 Roland Morris Disability Questionnaire(RMDQ)를 사용하여 요통으로 인한 장애를 평가합니다. RMDQ 점수는 검사 항목의 총 수이며 범위는 0에서 24까지이며 점수가 높을수록 장애가 심한 것을 나타냅니다.
기준선, 12주차
Change From Baseline in Pain Intensity Over Time Using NRS Scale
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BioDelivery Sciences International

수사관

  • 연구 책임자: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 11월 1일

기본 완료 (실제)

2011년 7월 1일

연구 완료 (실제)

2011년 7월 1일

연구 등록 날짜

최초 제출

2010년 12월 7일

QC 기준을 충족하는 최초 제출

2010년 12월 7일

처음 게시됨 (추정)

2010년 12월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 12일

마지막으로 확인됨

2017년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BUP-301

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