Trial · NCT01685684
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
NCT01685684, Phase 3, Completed, Collegium Pharmaceutical, Inc.; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP). Trials, record NCT01685684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01685684
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
- NCT number
- NCT01685684
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 740 participants, actual
- Lead sponsor
- Collegium Pharmaceutical, Inc.
- Conditions
- Chronic Low Back Pain
- Interventions
- Oxycodone DETERx, Placebo
- First posted
- 2012-09-14
- Last updated
- 2020-10-19
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | Randomized Baseline through Week 12 | The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Time-to-exit From the Study for All Causes | Randomization Baseline through Week 12 | Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module. |
| Secondary | Percent Reduction in Pain Intensity for Responders | Screening Baseline through Week 12 | Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity. |
| Secondary | Weekly Changes in Pain Intensity | Randomization Baseline and weekly through Week 12 | Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain). |
| Secondary | Rescue Medication Usage by Dose | Randomization Baseline through Week 12 | Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study) |
| Secondary | Rescue Medication Use by Dosage | Randomization Baseline through Week 12 | Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study) |
| Secondary | Patient Global Impression of Change (PGIC) | Screening Baseline through Week 12 | The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes "very much improved", "improved", "a little improved", "no change", "a little worse", "worse", and "very much worse". |
| Secondary | Changes in Quality of Life | Randomization Baseline through Week 12 | Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12. |
| Secondary | Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) | Randomization Baseline and Week 12 | The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | Randomized Baseline through Week 12 | One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Time-to-exit From the Study for All Causes | Randomization Baseline through Week 12 | Days | NUMBER | |
| SECONDARY | Percent Reduction in Pain Intensity for Responders | Screening Baseline through Week 12 | participants | NUMBER | |
| SECONDARY | Weekly Changes in Pain Intensity | Randomization Baseline and weekly through Week 12 | units on a scale | MEAN | |
| SECONDARY | Rescue Medication Usage by Dose | Randomization Baseline through Week 12 | doses | MEAN | |
| SECONDARY | Rescue Medication Use by Dosage | Randomization Baseline through Week 12 | milligrams | MEAN | |
| SECONDARY | Patient Global Impression of Change (PGIC) | Screening Baseline through Week 12 | participants | NUMBER | |
| SECONDARY | Changes in Quality of Life | Randomization Baseline through Week 12 | units on a scale | MEAN | |
| SECONDARY | Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ) | Randomization Baseline and Week 12 | The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | Oxycodone DETERx (Double-blind Maintenance Phase) | 0.29 | Standard Error 0.146 | units on a scale | |
| Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase | Placebo (Double-blind Maintenance Phase) | 1.85 | Standard Error 0.223 | units on a scale | |
| Time-to-exit From the Study for All Causes | Oxycodone DETERx (Double-blind Maintenance Phase) | 58.0 | 95% Confidence Interval 37.0 to 78.0 | Days | |
| Time-to-exit From the Study for All Causes | Placebo (Double-blind Maintenance Phase) | 35.0 | 95% Confidence Interval 29.0 to 38.0 | Days | |
| Percent Reduction in Pain Intensity for Responders | Oxycodone DETERx (Double-blind Maintenance Phase) | Subjects with 30% Improvement | 95 | participants | |
| Percent Reduction in Pain Intensity for Responders | Placebo (Double-blind Maintenance Phase) | Subjects with 30% Improvement | 65 | participants | |
| Percent Reduction in Pain Intensity for Responders | Oxycodone DETERx (Double-blind Maintenance Phase) | Subjects with 50% Improvement | 74 | participants | |
| Percent Reduction in Pain Intensity for Responders | Placebo (Double-blind Maintenance Phase) | Subjects with 50% Improvement | 48 | participants | |
| Weekly Changes in Pain Intensity | Oxycodone DETERx (Double-blind Maintenance Phase) | Week 1 | 0.1 | Standard Deviation 0.85 | units on a scale |
| Weekly Changes in Pain Intensity | Placebo (Double-blind Maintenance Phase) | Week 1 | 0.3 | Standard Deviation 1.17 | units on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Phase | STARTED | Oxycodone DETERx (Titration Phase) | 740 | |
| Titration Phase | STARTED | Oxycodone DETERx (Double-blind Maintenance Phase) | 0 | |
| Titration Phase | STARTED | Placebo (Double-blind Maintenance Phase) | 0 | |
| Titration Phase | COMPLETED | Oxycodone DETERx (Titration Phase) | 389 | |
| Titration Phase | COMPLETED | Oxycodone DETERx (Double-blind Maintenance Phase) | 0 | |
| Titration Phase | COMPLETED | Placebo (Double-blind Maintenance Phase) | 0 | |
| Titration Phase | NOT COMPLETED | Oxycodone DETERx (Titration Phase) | 351 | |
| Titration Phase | NOT COMPLETED | Oxycodone DETERx (Double-blind Maintenance Phase) | 0 | |
| Titration Phase | NOT COMPLETED | Placebo (Double-blind Maintenance Phase) | 0 | |
| Double-blind Maintenance Phase | STARTED | Oxycodone DETERx (Titration Phase) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events80
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 | Screening | 0 | 0 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone DETERx (Titration Phase) | 123 | 740 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone DETERx (Double-blind Maintenance Phase) | 21 | 193 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Double-blind Maintenance Phase) | 9 | 196 | |
| other | Headache | Nervous system disorders | Screening | 0 | 0 | |
| other | Headache | Nervous system disorders | Oxycodone DETERx (Titration Phase) | 103 | 740 | |
| other | Headache | Nervous system disorders | Oxycodone DETERx (Double-blind Maintenance Phase) | 12 | 193 | |
| other | Headache | Nervous system disorders | Placebo (Double-blind Maintenance Phase) | 23 | 196 | |
| other | Constipation | Gastrointestinal disorders | Screening | 0 | 0 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone DETERx (Titration Phase) | 96 | 740 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Screening | ||
| Total, all-cause mortality | Oxycodone DETERx (Titration Phase) | ||
| Total, all-cause mortality | Oxycodone DETERx (Double-blind Maintenance Phase) | ||
| Total, all-cause mortality | Placebo (Double-blind Maintenance Phase) | ||
| Total, other adverse events | Screening | 0 | 0 |
| Total, other adverse events | Oxycodone DETERx (Titration Phase) | 531 | 740 |
| Total, other adverse events | Oxycodone DETERx (Double-blind Maintenance Phase) | 60 | 193 |
| Total, other adverse events | Placebo (Double-blind Maintenance Phase) | 39 | 196 |
| Total, serious adverse events | Screening | 2 | 1,297 |
| Total, serious adverse events | Oxycodone DETERx (Titration Phase) | 8 | 740 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT01685684
GET https://conductscience.org/api/trials/v1/NCT01685684/results?page=2