Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

Chronic Non-malignant Pain Clinical Trial

Official title:

An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312195
• Other study ID #: BUP3201
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2006
• Last updated: September 5, 2012
• Start date: March 2001
• Est. completion date: July 2001

Study information

• Verified date: September 2012
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Description:

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.

• Good, very good or excellent pain control on current opioid therapy.

• Willing and able to use a telephone interactive voice response service.

Exclusion Criteria:

• Currently receiving daily morphine or oxycodone monotherapy.

• Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Chronic Non-malignant Pain

Intervention

Drug:
• Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
• Placebo to match BTDS
Placebo to match buprenorphine transdermal patch applied for 7-day wear.

Locations

Country	Name	City	State
United Kingdom	Ashvale Health Centre	Aldershot	Hants
United Kingdom	Springhill Surgery	Bangor	Co Down
United Kingdom	Little Common Surgery	Bexhill-on-Sea	E Sussex
United Kingdom	Old Town Surgery	Bexhill-on-Sea	E Sussex
United Kingdom	The Ridge Medical Practice, Great Horton	Bradford	West Yorkshire
United Kingdom	The Academy Medical Practice	Coatbridge	Lanarkshire
United Kingdom	Gables Medical Section	Coventry	Warwickshire
United Kingdom	The Burns Practice	Doncaster	S Yorkshire
United Kingdom	Castlemilk Health Centre	Glasgow
United Kingdom	Townhead Health Centre	Glasgow
United Kingdom	Leslie Surgery	Glenrothes	Fife
United Kingdom	Roebuck House Surgery	Hastings	E Sussex
United Kingdom	Valleyfield Health Centre	High Valleyfield	Fife
United Kingdom	Houston Surgery	Houston	Renfrewshire
United Kingdom	Bennett Road Surgery	Keresley End	Coventry
United Kingdom	Antrim Coast Fundholding Group	Lame	Co Antrim
United Kingdom	Garden Street Surgery	Magherafelt	Co Derry
United Kingdom	Whiteabbey Health Centre	Newtownabbey	Belfast
United Kingdom	Portglenone Health Centre	Portglenone	CO Antrim
United Kingdom	Sanbury Health Centre Group Practice	Sunbury-on-Thames	Middx
United Kingdom	Grosvenor Medical Centre	Tunbridge Wells	W Sussex
United States	Radiant Research	Austin	Texas
United States	Private Practice	Chardon	Ohio
United States	The Arthritis Clinic	Charlotte	North Carolina
United States	Tampa Bay Medical Research Inc	Clearwater	Florida
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Southeastern Center for Headache and Pain	Crestview Heights	Kentucky
United States	University Clinical Research Deland	Deland	Florida
United States	Family Medicine Associates	Evansville	Indiana
United States	Cornerstone Research Care	High Point	North Carolina
United States	Westside Family Medical Center PC	Kalamazoo	Michigan
United States	Summit Research Solutions	Memphis	Tennessee
United States	Clinical Research Management	New Berlin	Wisconsin
United States	University Clinical Research Inc,	Pembroke Pines	Florida
United States	Arizona Research Center Inc	Phoenix	Arizona
United States	Hawthorne and York	Phoenix	Arizona
United States	Gold Coast Research LLC	Plantation	Florida
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Gold Coast Research LLC	Tamarac	Florida
United States	Pain Management and Rehabilitation	Terre Haute	Indiana
United States	Clinical Research Consultants Inc	Trumbull	Connecticut
United States	ALL-TRIALS Clinical Research LLC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Purdue Pharma LP	Napp Pharmaceuticals Limited

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.	Ineffective treatment was defined as: Subject took >1 gram of acetaminophen in a 24-hour period, or; Subject required a change in transdermal patch (TDS) dose, or; Subject had difficulty in keeping the TDS on, or; Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).; Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.	Double-blind phase (14 days)	No
Secondary	Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment	The time of ineffective treatment was calculated as the earliest of the following: The date the subject first took >1 gram of acetaminophen,; The visit date when ineffective treatment was first determined, or; The date the last patch was removed.	14 days	No
Secondary	The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase	Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.	14 days	No
Secondary	The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).	The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.	14 days	No

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