Clinical trial NCT00315445: The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
Official title: A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain
Keywords: chronic back pain
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-18
Enrollment: 134
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 assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five 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:

* clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion Criteria:

* receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
* scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
timeFrame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
measure: Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
timeFrame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Secondary outcomes:
measure: "Physical Functioning" Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)
timeFrame: Day 84, or, if applicable, at early termination
measure: "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
timeFrame: Day 84
measure: "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
timeFrame: Day 84
measure: "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
timeFrame: Day 84
measure: "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
timeFrame: Day 84
measure: "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
timeFrame: Day 84
measure: "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
timeFrame: Day 84
measure: "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
timeFrame: Day 84
measure: Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
timeFrame: Day 84
measure: Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
timeFrame: Day 84
measure: Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
timeFrame: Day 84
measure: Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
timeFrame: Day 84
measure: Time to Stable Pain Management
timeFrame: Start of study to day 21.
measure: The Time to Discontinuation Due to Lack of Efficacy
timeFrame: Time after dosing to dropout due to lack of efficacy
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Center for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Orthopedic Center, Ltd.
state: Arizona
city: Gainesville
country: United States
facility: Gainesville Clinical Research Center
state: Florida
city: Miami
country: United States
facility: SeaView Research
state: Florida
city: Plantation
country: United States
facility: Park Place Therapeutic Center
state: Florida
city: Decatur
country: United States
facility: Atlanta Research Center
state: Georgia
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: Linwood
country: United States
facility: New Jersey Research Foundation
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Clinical Research, Inc.
state: North Carolina
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
References: