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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256450
• Other study ID #: BUP-301
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2010
• Last updated: January 4, 2016
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2016
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

Drug:
• Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
• Placebo
buccal soluble film; applied to the buccal mucosa twice daily

Locations

Country	Name	City	State
United States	Allegheny Pain Management	Altoona	Pennsylvania
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Alabama Orthopaedic Center - Research	Birmingham	Alabama
United States	Millennium Pain Center	Bloomington	Illinois
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Southwest Urgent Care Center	El Paso	Texas
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Neuro-Pain Medical Center	Fresno	California
United States	Health Awareness, Inc.	Jupiter	Florida
United States	University of California, San Diego Medical Center, UCSD Center for Pain Medicine	La Jolla	California
United States	Office of Stephen H. Miller, MD	Las Vegas	Nevada
United States	International Clinical Research Institute	Leawood	Kansas
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	Taylor Research, LLC	Marietta	Georgia
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Research Across American	New York	New York
United States	Arizona Research Center	Phoenix	Arizona
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Advanced Clinical Research	West Jordan	Utah
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity From Baseline to 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	No
Secondary	Change From Baseline in Pain Intensity Over Time Using NRS Scale	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	No
Secondary	Number of Participants With Response to Treatment as Assessed by an NRS Scale	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	No
Secondary	Percentage of Participants With Treatment Failure in the 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)	No
Secondary	Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale	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	No
Secondary	Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM	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	No
Secondary	Change From Baseline to Week 12 in Roland Morris Disability Questionnaire	Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.	Baseline, Week 12	No
Secondary	Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug	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	No
Secondary	Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug	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	No
Secondary	Use of Rescue Medication	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	No