Trial · NCT00315445
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
NCT00315445, Phase 3, Completed, Purdue Pharma LP; results first posted 2011-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. Trials, record NCT00315445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00315445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
- NCT number
- NCT00315445
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 134 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Back Pain
- Interventions
- Buprenorphine transdermal patch, Placebo oxycodone/acetaminophen tablets, OXY/APAP, Placebo transdermal patch (TDS)
- First posted
- 2006-04-18
- Last updated
- 2012-09-03
- Results first posted
- 2011-08-10
- Limitations and caveats
- There was a large percentage of discontinuations across treatment groups.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | 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. |
| Primary | Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) | Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | 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). |
| Secondary | "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) | Day 84, or, if applicable, at early termination | 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. |
| Secondary | "Physical Role" Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | Day 84 | 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. |
| Secondary | "Bodily Pain" (MOS SF-36): Mean Percent at Day 84 (LOCF) | Day 84 | 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. |
| Secondary | "General Health" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. |
| Secondary | "Vitality" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. |
| Secondary | "Social Functioning" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. |
| Secondary | "Emotional Role" (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. |
| Secondary | "Mental Health" (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Day 84, or, if applicable, at early termination | 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. | Units on a scale | MEAN |
| SECONDARY | Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| PRIMARY | Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) | Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| SECONDARY | General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| SECONDARY | Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| SECONDARY | Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| SECONDARY | Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
| SECONDARY | Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | 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. | Units on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | Placebo | -1.01 | Standard Error 0.37 | Units on a scale | |
| Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | OXY/APAP | -1.82 | Standard Error 0.36 | Units on a scale | |
| Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | BTDS | -1.92 | Standard Error 0.34 | Units on a scale | |
| 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) | Placebo | 46.4 | Standard Error 4.0 | Units on a scale | |
| 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) | OXY/APAP | 44.5 | Standard Error 3.9 | Units on a scale | |
| 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) | BTDS | 46.5 | Standard Error 3.6 | Units on a scale | |
| Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | Placebo | 18.9 | Standard Error 4.8 | Units on a scale | |
| Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | OXY/APAP | 24.4 | Standard Error 5.9 | Units on a scale | |
| Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | BTDS | 33.9 | Standard Error 5.8 | Units on a scale | |
| Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) | Placebo | -0.80 | Standard Error 0.38 | Units on a scale |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 45 | |
| Overall Study | STARTED | OXY/APAP | 43 | |
| Overall Study | STARTED | BTDS | 46 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | OXY/APAP | 27 | |
| Overall Study | COMPLETED | BTDS | 22 | |
| Overall Study | NOT COMPLETED | Placebo | 27 | |
| Overall Study | NOT COMPLETED | OXY/APAP | 16 | |
| Overall Study | NOT COMPLETED | BTDS | 24 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Placebo | 1 | 45 | |
| other | Asthenia | General disorders | OXY/APAP | 3 | 43 | |
| other | Asthenia | General disorders | BTDS | 2 | 46 | |
| other | Fever | General disorders | Placebo | 0 | 45 | |
| other | Fever | General disorders | OXY/APAP | 1 | 43 | |
| other | Fever | General disorders | BTDS | 3 | 46 | |
| other | Headache | General disorders | Placebo | 6 | 45 | |
| other | Headache | General disorders | OXY/APAP | 7 | 43 | |
| other | Headache | General disorders | BTDS | 13 | 46 | |
| other | Pain abdomen | General disorders | Placebo | 3 | 45 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | OXY/APAP | ||
| Total, all-cause mortality | BTDS | ||
| Total, other adverse events | Placebo | 20 | 45 |
| Total, other adverse events | OXY/APAP | 35 | 43 |
| Total, other adverse events | BTDS | 37 | 46 |
| Total, serious adverse events | Placebo | 2 | 45 |
| Total, serious adverse events | OXY/APAP | 3 | 43 |
| Total, serious adverse events | BTDS | 3 | 46 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00315445
GET https://conductscience.org/api/trials/v1/NCT00315445/outcomes?page=2