Trial · NCT00449176
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
NCT00449176, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain. Trials, record NCT00449176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449176
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
- NCT number
- NCT00449176
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 981 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Low Back Pain
- Interventions
- tapentadol (CG5503) ER, oxycodone CR, placebo
- First posted
- 2007-03-20
- Last updated
- 2012-04-30
- Results first posted
- 2010-06-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 weeks | For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". |
| Secondary | Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | Total pain score where zero equals "no pain" to ten equals "pain as bad as you can imagine" from 12 week endpoint vs baseline. |
| Secondary | Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | A Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement. |
| Secondary | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) |
| Secondary | Number of Participants With Treatment Discontinuation Due to Lack of Efficacy | Baseline and 12 weeks | The number of participants who discontinued due to lack of efficacy from baseline to endpoint |
| Secondary | Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12 | Baseline and 12 week endpoint | Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. |
| Secondary | Responder Analysis 50% Improvement | Baseline and Week 12 | Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 weeks | Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | hours | MEAN |
| SECONDARY | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Discontinuation Due to Lack of Efficacy | Baseline and 12 weeks | Intent to Treat Analysis Set | participants | NUMBER |
| SECONDARY | Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12 | Baseline and 12 week endpoint | Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis. | scores on a scale | MEAN |
| SECONDARY | Responder Analysis 50% Improvement | Baseline and Week 12 | Intent to Treat Analysis Set | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Tapentadol ER | -2.9 | Standard Deviation 2.66 | scores on a scale | |
| Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Oxycodone CR | -2.9 | Standard Deviation 2.52 | scores on a scale | |
| Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Placebo | -2.1 | Standard Deviation 2.33 | scores on a scale | |
| Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Tapentadol ER | -2.3 | Standard Deviation 2.25 | scores on a scale | |
| Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Oxycodone CR | -2.1 | Standard Deviation 2.35 | scores on a scale | |
| Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12. | Placebo | -1.6 | Standard Deviation 2.11 | scores on a scale | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Tapentadol ER | -0.2 | Standard Deviation 3.08 | hours | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Oxycodone CR | -0.2 | Standard Deviation 2.32 | hours | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Placebo | -0.1 | Standard Deviation 2.43 | hours | |
| Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Tapentadol ER | 55.5 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapentadol ER | 318 | |
| Overall Study | STARTED | Oxycodone CR | 328 | |
| Overall Study | STARTED | Placebo | 319 | |
| Overall Study | COMPLETED | Tapentadol ER | 166 | |
| Overall Study | COMPLETED | Oxycodone CR | 133 | |
| Overall Study | COMPLETED | Placebo | 152 | |
| Overall Study | NOT COMPLETED | Tapentadol ER | 152 | |
| Overall Study | NOT COMPLETED | Oxycodone CR | 195 | |
| Overall Study | NOT COMPLETED | Placebo | 167 |
Source ClinicalTrials.gov
Adverse events123
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 | Tapentadol ER | 44 | 318 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone CR | 88 | 328 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 16 | 319 | |
| other | Diarrhea | Gastrointestinal disorders | Tapentadol ER | 19 | 318 | |
| other | Diarrhea | Gastrointestinal disorders | Oxycodone CR | 8 | 328 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 23 | 319 | |
| other | Dizziness | Nervous system disorders | Tapentadol ER | 38 | 318 | |
| other | Dizziness | Nervous system disorders | Oxycodone CR | 55 | 328 | |
| other | Dizziness | Nervous system disorders | Placebo | 18 | 319 | |
| other | Dry Mouth | Gastrointestinal disorders | Tapentadol ER | 26 | 318 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol ER | ||
| Total, all-cause mortality | Oxycodone CR | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tapentadol ER | 192 | 318 |
| Total, other adverse events | Oxycodone CR | 240 | 328 |
| Total, other adverse events | Placebo | 118 | 319 |
| Total, serious adverse events | Tapentadol ER | 8 | |
| Total, serious adverse events | Oxycodone CR | 11 | |
| Total, serious adverse events | Placebo | 3 |
Source ClinicalTrials.gov
Papers5
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/NCT00449176
GET https://conductscience.org/api/trials/v1/NCT00449176/results?page=2