Trial · NCT01358526
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
NCT01358526, Phase 3, Completed, Purdue Pharma LP; results first posted 2014-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain. Trials, record NCT01358526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358526
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
- NCT number
- NCT01358526
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,095 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Low Back Pain
- Interventions
- Oxycodone/Naloxone Controlled-release, Placebo
- First posted
- 2011-05-23
- Last updated
- 2015-11-11
- Results first posted
- 2014-09-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period | 24 hours (Week 12) | The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine. |
| Secondary | The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 | The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance. |
| Secondary | Patient Global Impression of Change (PGIC) | Week 12 | The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test. |
| Other | Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline | Week 12 | A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period. |
| Other | Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline | Week 12 | A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period | 24 hours (Week 12) | The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | units on a scale (0 - 10) | MEAN |
| SECONDARY | The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 | The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) | Week 12 | The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | participants (responders) | NUMBER |
| OTHER_PRE_SPECIFIED | Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline | Week 12 | The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | participants (responders) | NUMBER |
| OTHER_PRE_SPECIFIED | Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline | Week 12 | The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | participants (responders) | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period | OXN Group | 3.86 | Standard Error 0.116 | units on a scale (0 - 10) | |
| The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period | Placebo Group | 4.32 | Standard Error 0.115 | units on a scale (0 - 10) | |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | OXN Group | Week 4 | 32.5 | 95% Confidence Interval 29.4 to 35.7 | units on a scale |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | Placebo Group | Week 4 | 38.0 | 95% Confidence Interval 34.8 to 41.3 | units on a scale |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | OXN Group | Week 8 | 30.8 | 95% Confidence Interval 27.8 to 33.9 | units on a scale |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | Placebo Group | Week 8 | 36.8 | 95% Confidence Interval 33.6 to 39.9 | units on a scale |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | OXN Group | Week 12 | 31.1 | 95% Confidence Interval 28.1 to 34.2 | units on a scale |
| The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 | Placebo Group | Week 12 | 36.4 | 95% Confidence Interval 33.2 to 39.7 | units on a scale |
| Patient Global Impression of Change (PGIC) | OXN Group | 153 | participants (responders) | ||
| Patient Global Impression of Change (PGIC) | Placebo Group | 109 | participants (responders) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Titration Period | STARTED | Open-label Titration OXN | 1,095 | |
| Open-label Titration Period | STARTED | OXN Group | 0 | |
| Open-label Titration Period | STARTED | Placebo Group | 0 | |
| Open-label Titration Period | COMPLETED | Open-label Titration OXN | 601 | |
| Open-label Titration Period | COMPLETED | OXN Group | 0 | |
| Open-label Titration Period | COMPLETED | Placebo Group | 0 | |
| Open-label Titration Period | NOT COMPLETED | Open-label Titration OXN | 494 | |
| Open-label Titration Period | NOT COMPLETED | OXN Group | 0 | |
| Open-label Titration Period | NOT COMPLETED | Placebo Group | 0 | |
| Double-blind Phase | STARTED | Open-label Titration OXN | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events99
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 | Nausea | Gastrointestinal disorders | Open-label Titration OXN | 79 | 1,095 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Placebo | 14 | 302 | |
| other | Nausea | Gastrointestinal disorders | Double-blind OXN | 25 | 298 | |
| other | Drug screen positive | Investigations | Open-label Titration OXN | 23 | 1,095 | |
| other | Drug screen positive | Investigations | Double-blind Placebo | 20 | 302 | |
| other | Drug screen positive | Investigations | Double-blind OXN | 19 | 298 | |
| serious | Acute myocardial infarction | Cardiac disorders | Open-label Titration OXN | 0 | 1,095 | |
| serious | Acute myocardial infarction | Cardiac disorders | Double-blind Placebo | 2 | 302 | |
| serious | Acute myocardial infarction | Cardiac disorders | Double-blind OXN | 0 | 298 | |
| serious | Angina pectoris | Cardiac disorders | Open-label Titration OXN | 0 | 1,095 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Titration OXN | ||
| Total, all-cause mortality | Double-blind Placebo | ||
| Total, all-cause mortality | Double-blind OXN | ||
| Total, other adverse events | Open-label Titration OXN | 79 | 1,095 |
| Total, other adverse events | Double-blind Placebo | 34 | 302 |
| Total, other adverse events | Double-blind OXN | 41 | 298 |
| Total, serious adverse events | Open-label Titration OXN | 11 | 1,095 |
| Total, serious adverse events | Double-blind Placebo | 12 | 302 |
| Total, serious adverse events | Double-blind OXN | 19 | 298 |
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/NCT01358526
GET https://conductscience.org/api/trials/v1/NCT01358526/events?page=2