Trial · NCT01452529
Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
NCT01452529, Phase 3, Completed, Purdue Pharma LP; results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain. Trials, record NCT01452529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01452529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
- NCT number
- NCT01452529
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 905 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Chronic Low Back Pain
- Interventions
- Hydrocodone bitartrate q24h film-coated tablets, Placebo to match hydrocodone bitartrate q24h tablets
- First posted
- 2011-10-17
- Last updated
- 2020-03-10
- Results first posted
- 2014-12-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score | Week 12 | Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine). |
| Secondary | Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Weeks 4, 8, and 12 | The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern. |
| Secondary | Patient Global Impression of Change (PGIC) | Week 12 | The PGIC is an ordinal scale which assesses 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 "very much improved" and "much improved" was summarized by treatment group. |
| Secondary | Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline | Baseline to Week 12 | A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period. |
| Secondary | Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline | Baseline to Week 12 | A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at 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 | Mean Pain Intensity for Average Pain Over the Last 24 Hours Score | Week 12 | The full analysis population (N = 588) 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 | Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Weeks 4, 8, and 12 | The full analysis population (N = 588) 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 (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | Participants | NUMBER |
| SECONDARY | Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline | Baseline to Week 12 | The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | Participants | NUMBER |
| SECONDARY | Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline | Baseline to Week 12 | The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Pain Intensity for Average Pain Over the Last 24 Hours Score | Hydrocodone Bitartrate | 3.7 | Standard Error 0.13 | units on a scale | |
| Mean Pain Intensity for Average Pain Over the Last 24 Hours Score | Placebo | 4.2 | Standard Error 0.13 | units on a scale | |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Hydrocodone Bitartrate | Screening | 44.38 | Standard Deviation 9.262 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Placebo | Screening | 44.72 | Standard Deviation 9.871 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Hydrocodone Bitartrate | Week 4 | 50.38 | Standard Deviation 8.851 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Placebo | Week 4 | 50.51 | Standard Deviation 9.156 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Hydrocodone Bitartrate | Week 8 | 50.16 | Standard Deviation 8.879 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Placebo | Week 8 | 51.16 | Standard Deviation 8.781 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Hydrocodone Bitartrate | Week 12 | 51.57 | Standard Deviation 8.576 | units on a scale |
| Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale | Placebo | Week 12 | 52.12 | Standard Deviation 8.779 | units on a scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period | STARTED | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 905 | |
| Run-in Period | STARTED | Hydrocodone Bitartrate | 0 | |
| Run-in Period | STARTED | Placebo | 0 | |
| Run-in Period | COMPLETED | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 592 | |
| Run-in Period | COMPLETED | Hydrocodone Bitartrate | 0 | |
| Run-in Period | COMPLETED | Placebo | 0 | |
| Run-in Period | NOT COMPLETED | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 313 | |
| Run-in Period | NOT COMPLETED | Hydrocodone Bitartrate | 0 | |
| Run-in Period | NOT COMPLETED | Placebo | 0 | |
| Double-blind (DB) Period | STARTED | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events78
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 Run-in Dose-titration Period Hydrocodone Bitartrate | 144 | 905 | |
| other | Nausea | Gastrointestinal disorders | Hydrocodone Bitartrate | 24 | 296 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 16 | 292 | |
| other | Constipation | Gastrointestinal disorders | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 85 | 905 | |
| other | Constipation | Gastrointestinal disorders | Hydrocodone Bitartrate | 10 | 296 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 7 | 292 | |
| other | Vomiting | Gastrointestinal disorders | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 65 | 905 | |
| other | Vomiting | Gastrointestinal disorders | Hydrocodone Bitartrate | 18 | 296 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 9 | 292 | |
| other | Dizziness | Nervous system disorders | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 64 | 905 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | ||
| Total, all-cause mortality | Hydrocodone Bitartrate | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 265 | 905 |
| Total, other adverse events | Hydrocodone Bitartrate | 52 | 296 |
| Total, other adverse events | Placebo | 30 | 292 |
| Total, serious adverse events | Open-label Run-in Dose-titration Period Hydrocodone Bitartrate | 7 | 905 |
| Total, serious adverse events | Hydrocodone Bitartrate | 2 | 296 |
| Total, serious adverse events | Placebo | 4 | 292 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01452529
GET https://conductscience.org/api/trials/v1/NCT01452529/results?page=2