Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects

Low Back Pain Clinical Trial

Official title:

Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675167
• Other study ID #: EN3409-307
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2012
• Last updated: January 4, 2016
• Start date: September 2012
• Est. completion date: June 2014

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 the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of moderate to severe low back pain for =6 months

• Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to =30 mg and =160 mg morphine sulfate equivalents (MSE) per day for =4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of =30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)

• Stable health, as determine by Principal Investigator

• Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year

• Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

• Current cancer related pain or received chemotherapy within 6 months of screening

• Subjects with history of other chronic painful conditions

• Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis

• Allergy or contraindications of any opioid or acetaminophen

• Surgical procedure for relief of pain within 6 months

• Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia

• QT interval corrected using Fridericia's formula (QTcF) of =450 milliseconds on the 12-lead electrocardiogram (ECG)

• History of long QT syndrome or a family member with this condition

• Moderate to severe hepatic impairment

• Moderate to severe renal impairment

• Current or past history of alcohol abuse

• Positive urine toxicology screen for drug of abuse

• History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
• Placebo
Matching Placebo Buccal Film twice daily

Locations

Country	Name	City	State
United States	Global Research	Anaheim	California
United States	Atlanta Research Center	Atlanta	Georgia
United States	FutureSearch Clinical Trials	Austin	Texas
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Clinical Inquest Center, Ltd	Beavercreek	Ohio
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	The Center for Clinical Trials	Biloxi	Mississippi
United States	Parkway Medical Center	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Willis-Kinghton Physician Network / River Cities International Pain Specialist	Bossier City	Louisiana
United States	Catalina Research Institute, LLC	Chino	California
United States	New Horizons Health Research	Cincinnati	Ohio
United States	Future Search Trials of Dallas, LP	Dallas	Texas
United States	KRK Medical Research	Dallas	Texas
United States	Century Clinic Research	Daytona Beach	Florida
United States	Avail Clinical Research, LLC	Deland	Florida
United States	Brandywine Clinical Research	Downingtown	Pennsylvania
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Synergy Clinical Research Center of Escondido	Escondido	California
United States	MediSphere Medical Research, LLC	Evansville	Indiana
United States	Plains Medical Clinic, LLC	Fargo	North Dakota
United States	Prestige Clinical Research	Franklin	Ohio
United States	Florida Health Center	Ft. Lauderdale	Florida
United States	RX Clinical Research, Inc.	Garden Grove	California
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	PharmQuest, LLC	Greensboro	North Carolina
United States	Clinical Investigations Specialists, Inc.	Gurnee	Illinois
United States	Haleyville Clinical Research LLC	Haleyville	Alabama
United States	Eastern Research, Inc.	Hialeah	Florida
United States	Advanced Clinical Research of Houston	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Florida Institute of Medical Research	Jacksonville	Florida
United States	Drug Study Institute	Jupiter	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	FPA Clinical Research	Kissimmee	Florida
United States	Office of Robert Kaplan, DO	Las Vegas	Nevada
United States	Adam D. Karns, MD	Los Angeles	California
United States	Try Research, Inc.	Maitland	Florida
United States	Drug Studies America	Marietta	Georgia
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia
United States	Taylor Research, LLC	Marietta	Georgia
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Horizon Research Group. Inc / Alabama Orthopedice	Mobile	Alabama
United States	NEMA Research, Inc.	Naples	Florida
United States	Best Clinical Trials, LLC	New Orleans	Louisiana
United States	Georgia Pain & Spine Care & Better Health Clinical Research	Newnan	Georgia
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center Research	Oklahoma City	Oklahoma
United States	Compass Research, LLC	Orlando	Florida
United States	Peninsula Research, Inc.	Ormond Beach	Florida
United States	International Clinical Research Institute, Inc.	Overland Park	Kansas
United States	Arizona Research Center	Phoenix	Arizona
United States	Gold Coast Research, LLC	Plantation	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Innovative Clinical Trials	San Antonio	Texas
United States	River Cities Clinical Research Center	Shreveport	Louisiana
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	MedVadis Research Corp.	Watertown	Massachusetts
United States	Integrated Clinical Trial Services, Inc	West Des Moines	Iowa
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	National Pain Research Institute, LLC	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Endo Pharmaceuticals	BioDelivery Sciences International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Average Daily Pain Intensity Scores	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	Number of Participants With Response to Treatment (Responder) Using NRS Scale	Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. 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).	Prior to open-label titration to week 12 in double-blind treatment	No
Secondary	Number of Subjects With Opioid Rescue Medication Use	Use of analgesic rescue medication recorded in subject diary	Week 1 to Week 12	No
Secondary	Time to Optimal Dose of Open-label Study Medication	Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment	Up to 8 weeks in open-label titration	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 discontinuation due to adverse events in the double-blind treatment phase.	Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)	No
Secondary	Patient Global Impression of Change	Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)	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 Medical Outcome Score Sleep Subscale	Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).	Baseline, Week 12	No
Secondary	Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep	Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is =7.	Week 12	No