Clinical trial NCT00312195: Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Non-malignant Pain
Keywords: Chronic pain
opioid
transdermal
Butrans™ [BTDS]
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
Collaborators: name: Napp Pharmaceuticals Limited
First posted: 2006-04-07
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
timeFrame: Double-blind phase (14 days)
Secondary outcomes:
measure: Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
timeFrame: 14 days
measure: The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
timeFrame: 14 days
measure: The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
timeFrame: 14 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hawthorne and York
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center Inc
state: Arizona
city: Trumbull
country: United States
facility: Clinical Research Consultants Inc
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Inc,
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Tamarac
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Evansville
country: United States
facility: Family Medicine Associates
state: Indiana
city: Terre Haute
country: United States
facility: Pain Management and Rehabilitation
state: Indiana
city: Crestview Heights
country: United States
facility: Southeastern Center for Headache and Pain
state: Kentucky
city: Kalamazoo
country: United States
facility: Westside Family Medical Center PC
state: Michigan
city: Charlotte
country: United States
facility: The Arthritis Clinic
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Winston-Salem
country: United States
facility: ALL-TRIALS Clinical Research LLC
state: North Carolina
city: Chardon
country: United States
facility: Private Practice
state: Ohio
city: Memphis
country: United States
facility: Summit Research Solutions
state: Tennessee
city: Austin
country: United States
facility: Radiant Research
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: New Berlin
country: United States
facility: Clinical Research Management
state: Wisconsin
city: Newtownabbey
country: United Kingdom
facility: Whiteabbey Health Centre
state: Belfast
city: Lame
country: United Kingdom
facility: Antrim Coast Fundholding Group
state: Co Antrim
city: Portglenone
country: United Kingdom
facility: Portglenone Health Centre
state: CO Antrim
city: Magherafelt
country: United Kingdom
facility: Garden Street Surgery
state: Co Derry
city: Bangor
country: United Kingdom
facility: Springhill Surgery
state: Co Down
city: Keresley End
country: United Kingdom
facility: Bennett Road Surgery
state: Coventry
city: Bexhill-on-Sea
country: United Kingdom
facility: Little Common Surgery
state: E Sussex
city: Bexhill-on-Sea
country: United Kingdom
facility: Old Town Surgery
state: E Sussex
city: Hastings
country: United Kingdom
facility: Roebuck House Surgery
state: E Sussex
city: Glenrothes
country: United Kingdom
facility: Leslie Surgery
state: Fife
city: High Valleyfield
country: United Kingdom
facility: Valleyfield Health Centre
state: Fife
city: Aldershot
country: United Kingdom
facility: Ashvale Health Centre
state: Hants
city: Coatbridge
country: United Kingdom
facility: The Academy Medical Practice
state: Lanarkshire
city: Sunbury-on-Thames
country: United Kingdom
facility: Sanbury Health Centre Group Practice
state: Middx
city: Houston
country: United Kingdom
facility: Houston Surgery
state: Renfrewshire
city: Doncaster
country: United Kingdom
facility: The Burns Practice
state: S Yorkshire
city: Tunbridge Wells
country: United Kingdom
facility: Grosvenor Medical Centre
state: W Sussex
city: Coventry
country: United Kingdom
facility: Gables Medical Section
state: Warwickshire
city: Bradford
country: United Kingdom
facility: The Ridge Medical Practice, Great Horton
state: West Yorkshire
city: Glasgow
country: United Kingdom
facility: Townhead Health Centre
city: Glasgow
country: United Kingdom
facility: Castlemilk Health Centre
Study officials:
References: