Trial · NCT02946073
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
NCT02946073, Phase 3, Completed, Braeburn Pharmaceuticals; results first posted 2021-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain. Trials, record NCT02946073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02946073
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
- NCT number
- NCT02946073
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Braeburn Pharmaceuticals
- Conditions
- Chronic Lower Back Pain, Chronic Pain
- Interventions
- buprenorphine, Placebo
- First posted
- 2016-10-26
- Last updated
- 2021-10-15
- Results first posted
- 2021-10-15
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain. |
| Primary | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects). | Change from baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects. |
| Secondary | Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain. | 12 weeks- from randomization baseline to 12 weeks after randomization | Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 12 of the Double-Blind Phase based on the 11-Point numerical rating scale with 0 being no pain and 10 being the worst pain. |
| Secondary | Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Number of Responders With a 30% and 50% Reduction in WAAPI from the Open-Label Titration Period Baseline to Week 12 of the Double-Blind Treatment Period (mITT Population) |
| Secondary | Summary of Rescue Medication Usage- Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Rescue medication usage (number of days used) during the Double-Blind Phase. |
| Secondary | Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score. | 12 weeks- from randomization baseline to 12 weeks after randomization | Change from Open Label Titration baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level self-report questionnaire score. The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) descriptive system is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood, using a 5-level scale. These combinations of attributes were converted into a weighted health-state index score, according to the US population-based algorithm, with higher scores indicating better quality of life. The score ranges from 0-100 with 0 as the worst health and 100 as the best health. |
| Secondary | Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score | 23 weeks- from baseline to 12 weeks after randomization | Change from baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment score. The Work Productivity and Activity Impairment (WPAI) is a self-administered instrument used to measure the effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores (higher scores indicate greater impairment): Absenteeism (work time missed)，Presenteeism (impairment at work/reduced on-the-job effectiveness), Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)，and Activity Impairment. Scores range from 0-100 for each of the four types with higher scores indicating greater impairment. |
| Secondary | Number of Subjects Discontinued Due to Loss of Efficacy | 12 weeks- from randomization baseline to 12 weeks after randomization | Number of Subjects Discontinued due to loss of efficacy, defined as discontinuation of study drug for lack of efficacy. |
| Secondary | Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale | 12 weeks- from baseline (randomization) to 12 weeks after randomization | Change from baseline to Week 12 of the Double-Blind Phase in Patient global Impression of Improvement (PGI-I) Scale. PGI-I)Scale is a single question 7-point likert scale that required the subject to assess how much his/her pain had improved or worsened relative to the start of the study at the beginning of the intervention . Ratings were: 1, much worse; 2, worse; 3, a little worse; 4, no change; 5, a little better; 6, better; or 7, much better |
| Secondary | Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase. | 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects). | Change from baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) and the primary timepoint will be Week 52 of the Open Label Phase based on the 11-Point numerical rating scale with 10 being the worst pain. Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects). | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Weekly Average of (Daily) Worst Pain Intensity Scores at Week 12 of the Double-Blind Phase Based on 11-Point Numerical Rating Scale With 10 Being the Worst Pain. | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | score on a scale | MEAN |
| SECONDARY | Number of Subjects With a 30% and 50% Reduction in WAAPI From Baseline to Week 12 of the Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Rescue Medication Usage- Double-Blind Phase. | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | Days | MEAN |
| SECONDARY | Change From Open Label Titration Baseline to Week 12 of the Double-Blind Phase in EuroQol Group 5-dimension 5-level Self-report Questionnaire Score. | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 of the Double-Blind Phase in Work Productivity and Activity Impairment Score | 23 weeks- from baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | score on a scale | MEAN |
| SECONDARY | Number of Subjects Discontinued Due to Loss of Efficacy | 12 weeks- from randomization baseline to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 12 of the Double-Blind Phase in Patient Global Impression of Improvement (PGI-I) Scale | 12 weeks- from baseline (randomization) to 12 weeks after randomization | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Average of (Daily) Worst Pain Intensity (WAWPI) of the Open Label Phase. | 48 weeks -From baseline to 48 weeks after baseline (Baseline is defined as the last week prior to Visit 14 (Randomization Visit) for the roll-over subjects and the last week prior to Visit 14 (Enrollment Visit) for de novo subjects). | Modified Intent-to-Treat (mITT) Population: The mITT Population consisted of all randomized subjects, with the exception of the subjects from Sites 068 and 077 due to persistent site non-compliance | score on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group207
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w | Baseline | 2.7 | Standard Deviation 1.26 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | Placebo Subcutaneous Injections | Baseline | 2.4 | Standard Deviation 1.25 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | CAM2038 (Buprenorphine FluidCrystal®) q1w and q4w | Change from Baseline to Week 12 | -0.9 | Standard Deviation 1.62 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) and the Primary Timepoint Will be Week 12 of the Double-Blind Phase. | Placebo Subcutaneous Injections | Change from Baseline to Week 12 | -1.9 | Standard Deviation 1.97 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | De Novo | Baseline | 2.839 | Standard Deviation 1.0753 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | CAM2038 | Baseline | 2.256 | Standard Deviation 1.1642 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | Rollover Placebo Injections | Baseline | 1.944 | Standard Deviation 1.1288 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | De Novo | Change from Baseline to Week 4 | -0.434 | Standard Deviation 0.94 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | CAM2038 | Change from Baseline to Week 4 | -0.531 | Standard Deviation 0.93 | score on a scale |
| Change From Baseline in Weekly Average of (Daily) Average Pain Intensity (WAAPI) of the Open Label Phase. | Rollover Placebo Injections | Change from Baseline to Week 4 | -1.586 | Standard Deviation 1.80 | score on a scale |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Phase | STARTED | CAM2038 q1w or q4w BPN Treatment- Double Blind Phase | 811 | |
| Titration Phase | STARTED | Placebo Subcutaneous Injections-Double Blind Phase | 0 | |
| Titration Phase | STARTED | De Novo Subjects-Open Label Phase | 98 | |
| Titration Phase | STARTED | Rollover Subjects-Open Label | 0 | |
| Titration Phase | COMPLETED | CAM2038 q1w or q4w BPN Treatment- Double Blind Phase | 222 | |
| Titration Phase | COMPLETED | Placebo Subcutaneous Injections-Double Blind Phase | 0 | |
| Titration Phase | COMPLETED | De Novo Subjects-Open Label Phase | 75 | |
| Titration Phase | COMPLETED | Rollover Subjects-Open Label | 0 | |
| Titration Phase | NOT COMPLETED | CAM2038 q1w or q4w BPN Treatment- Double Blind Phase | 589 | |
| Titration Phase | NOT COMPLETED | Placebo Subcutaneous Injections-Double Blind Phase | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events399
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 | Constipation | Gastrointestinal disorders | CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase | 25 | 468 | 25 |
| other | Constipation | Gastrointestinal disorders | CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase | 2 | 112 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase | 1 | 110 | 1 |
| other | Constipation | Gastrointestinal disorders | De Novo Subjects-Open Label, Titration Period Only | 4 | 75 | 4 |
| other | Constipation | Gastrointestinal disorders | Rollover Subjects-Open Label, Titration Period Only | 0 | 46 | 0 |
| other | Constipation | Gastrointestinal disorders | De Novo Subjects-Open Label, Enrollment Period Only | 1 | 54 | 1 |
| other | Constipation | Gastrointestinal disorders | Rollover Subjects-Open Label, Enrollment Period Only | 0 | 55 | 0 |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase | 87 | 468 | 87 |
| other | Nausea | Gastrointestinal disorders | CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase | 2 | 112 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase | 1 | 110 | 1 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase | 1 | 468 |
| Total, all-cause mortality | CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase | 0 | 112 |
| Total, all-cause mortality | Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase | 1 | 110 |
| Total, all-cause mortality | De Novo Subjects-Open Label, Titration Period Only | 0 | 75 |
| Total, all-cause mortality | Rollover Subjects-Open Label, Titration Period Only | 0 | 46 |
| Total, all-cause mortality | De Novo Subjects-Open Label, Enrollment Period Only | 0 | 54 |
| Total, all-cause mortality | Rollover Subjects-Open Label, Enrollment Period Only | 0 | 55 |
| Total, other adverse events | CAM2038 q1w or q4w BPN Treatment-Titration Period of Double Blind Phase | 300 | 468 |
| Total, other adverse events | CAM2038 q1w or q4w BPN Treatment- Double Blind Period of Double Blind Phase | 36 | 112 |
| Total, other adverse events | Placebo Subcutaneous Injections-Double Blind Period of Double Blind Phase | 32 | 110 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CAM2038 vs Placebo: Number of Subjects Discontinued Due to Loss of Efficacy |
Source Trial comparisons
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.
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