The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

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.

Population: All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.

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.

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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.

Time frame: Day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data.

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.

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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: Baseline to days 21 - 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation).

Time frame: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation).

Time frame: Baseline to day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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. Primary back pain was measured.

Time frame: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF).

Time frame: Baseline to days 21-84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.

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. This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF).

Time frame: Baseline to day 84

Population: All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained.