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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Buprenorphine 5, 10, or 20 mcg/hour patch applied transdermally for 7-day wear.
Placebo oxycodone/acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
5 mg oxycodone / 325 mg acetaminophen tablets; 1, 2, or 3 tablets taken four times/day.
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
Phoenix Center for Clinical Research
Phoenix, Arizona, United States
Phoenix Orthopedic Center, Ltd.
Phoenix, Arizona, United States
Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.
Time frame: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
Subjects were asked, "Please rate your pain by circling the one number (0-10) that tells how much pain you have right now." Subjects rated their answers on a 0-10 ordinal scale from 0 = "No pain" to 10 = "Pain as bad as you can imagine it." Pain right now is presented as the LSmean \[change from baseline\] (SE).
Time frame: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.
"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)
The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. "Physical Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Time frame: Day 84, or, if applicable, at early termination
"Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)
The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. "Physical Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
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Placebo transdermal patch 5, 10, or 20 applied transdermally for 7-day wear
Gainesville Clinical Research Center
Gainesville, Florida, United States
SeaView Research
Miami, Florida, United States
Park Place Therapeutic Center
Plantation, Florida, United States
Atlanta Research Center
Decatur, Georgia, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
New Jersey Research Foundation
Linwood, New Jersey, United States
North Carolina Clinical Research, Inc.
Raleigh, North Carolina, United States
...and 2 more locations
Time frame: Day 84
"Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Bodily Pain" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Time frame: Day 84
"General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "General Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed.
Time frame: Day 84
"Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Vitality" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed.
Time frame: Day 84
"Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Social Functioning" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Time frame: Day 84
"Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Emotional Role" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Time frame: Day 84
"Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)
The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. "Mental Health" is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic.
Time frame: Day 84
Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Time frame: Day 84
Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Time frame: Day 84
Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = "Worse than prestudy medicine" to 2 = "Better than prestudy medicine."
Time frame: Day 84
Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = "No response" to 3 = "Marked response."
Time frame: Day 84
Time to Stable Pain Management
For each subject, "time to stable pain management" is defined as the first (post-baseline) time during the titration period when his/her "diary pain" was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the "pain on the average" (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline).
Time frame: Start of study to day 21.
The Time to Discontinuation Due to Lack of Efficacy
Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P\< .10, using a backward elimination procedure.
Time frame: Time after dosing to dropout due to lack of efficacy