Trial · NCT00486811
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
NCT00486811, Phase 3, Completed, Grünenthal GmbH; results first posted 2011-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee. Trials, record NCT00486811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00486811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- NCT number
- NCT00486811
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 990 participants, actual
- Lead sponsor
- Grünenthal GmbH
- Conditions
- Pain, Knee Osteoarthritis
- Interventions
- Tapentadol ER (100 to 250 mg twice daily), Matching Placebo (twice daily), Oxycodone CR (20 to 50 mg twice daily)
- First posted
- 2007-06-15
- Last updated
- 2019-10-18
- Other registries' IDs
- eudract:2006-005783-67
- Results first posted
- 2011-01-11
Source ClinicalTrials.gov
Registered outcomes12
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 Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). | Change from baseline over the 12 week Maintenance Period | For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain. |
| Secondary | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Change from Baseline to Week 12 of the Maintenance Period | The twice daily pain assessments were averaged. The participants were to indicate their pain 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". The lower the value the less pain intensity. |
| Secondary | Patient Global Impression of Change | Baseline; End of 12 week maintenance period | In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
| Secondary | Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Change from baseline to week 12 of the maintenance period | Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling. |
| Secondary | Time to Treatment Discontinuation Due to Lack of Efficacy | Baseline to week 12 of the maintenance period | The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint. |
| Secondary | Change in the Health Survey Scores Form (SF-36) | Change From Baseline to Week 12 of the Maintenance Period | The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. |
| Secondary | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time | Comparison of Baseline to Week 12 of the Maintenance Period | The participant scored the EuroQol-5. This 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. The positive values indicate that during the study the health status improved. |
| Secondary | Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period. | Week 12 of the maintenance period compared to baseline | The Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night(hours)?". The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement. |
| Secondary | Sleep Questionnaire: Amount of Time Slept in Hours | Baseline to Week 12 of the maintenance period | The Sleep Questionnaire addressed the following question: "How long did you sleep last night?". The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied. |
| Secondary | Sleep Questionnaire: Number of Awakenings During Sleep | Week 12 of the maintenance period compared with baseline | The Sleep Questionnaire addressed the following question: "How many times did you wake up during the night?". Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). | Change from baseline over the 12 week Maintenance Period | Intent-to-treat (ITT), Last Observation Carried Forward (LOCF) | Units on a scale | MEAN |
| SECONDARY | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Change from Baseline to Week 12 of the Maintenance Period | Intention to treat (ITT). Last Observation Carried Forward (LOCF). | Units on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change | Baseline; End of 12 week maintenance period | Intention to treat (ITT). Last observation carried forward (LOCF). Assessments obtained more than one day after end of treatment were not included in the analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Change from baseline to week 12 of the maintenance period | Intention to treat (ITT). No imputation performed. | units on a scale | MEAN |
| SECONDARY | Time to Treatment Discontinuation Due to Lack of Efficacy | Baseline to week 12 of the maintenance period | Intention to treat (ITT) The results for median and interquartile ranges were not estimated as an insufficient number of participants discontinued due to lack of efficacy to estimate values. | ||
| SECONDARY | Change in the Health Survey Scores Form (SF-36) | Change From Baseline to Week 12 of the Maintenance Period | The number indicate the available responses. For certain categories, e.g. Physical Functioning only 318 participants in the tapentadol treatment were analyzed and in the General Health analysis only 328 oxycodone- and 336 placebo-treated participants were available. Intention to treat (ITT). Last Observation Carried Forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time | Comparison of Baseline to Week 12 of the Maintenance Period | Intention to treat (ITT). Last Observation Carried Forward (LOCF). | Index value | MEAN |
| SECONDARY | Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period. | Week 12 of the maintenance period compared to baseline | Intention to treat (ITT). Last Observation Carried Forward (LOCF). | hours | MEAN |
| SECONDARY | Sleep Questionnaire: Amount of Time Slept in Hours | Baseline to Week 12 of the maintenance period | Intention to treat (ITT). Last Observation Carried Forward (LOCF) | hours | MEAN |
| SECONDARY | Sleep Questionnaire: Number of Awakenings During Sleep | Week 12 of the maintenance period compared with baseline | Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number reflects the number of participants that had the specified awakenings. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group135
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 Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). | Placebo Matching | -2.2 | Standard Deviation 2.06 | Units on a scale | |
| Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). | Tapentadol ER | -2.5 | Standard Deviation 2.18 | Units on a scale | |
| Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). | Oxycodone CR | -2.1 | Standard Deviation 2.17 | Units on a scale | |
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Placebo Matching | -2.5 | Standard Deviation 2.30 | Units on a scale | |
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Tapentadol ER | -2.7 | Standard Deviation 2.4 | Units on a scale | |
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. | Oxycodone CR | -2.3 | Standard Deviation 2.36 | Units on a scale | |
| Patient Global Impression of Change | Placebo Matching | Very Much Improved | 33 | participants | |
| Patient Global Impression of Change | Tapentadol ER | Very Much Improved | 40 | participants | |
| Patient Global Impression of Change | Oxycodone CR | Very Much Improved | 25 | participants | |
| Patient Global Impression of Change | Placebo Matching | Much Improved | 94 | participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Matching | 337 | |
| Overall Study | STARTED | Tapentadol ER | 320 | |
| Overall Study | STARTED | Oxycodone CR | 333 | |
| Overall Study | COMPLETED | Placebo Matching | 215 | |
| Overall Study | COMPLETED | Tapentadol ER | 179 | |
| Overall Study | COMPLETED | Oxycodone CR | 119 | |
| Overall Study | NOT COMPLETED | Placebo Matching | 122 | |
| Overall Study | NOT COMPLETED | Tapentadol ER | 141 | |
| Overall Study | NOT COMPLETED | Oxycodone CR | 214 |
Source ClinicalTrials.gov
Adverse events108
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 | Placebo Matching | 21 | 337 | |
| other | Nausea | Gastrointestinal disorders | Tapentadol ER | 65 | 319 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone CR | 123 | 331 | |
| other | Constipation | Gastrointestinal disorders | Placebo Matching | 31 | 337 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol ER | 56 | 319 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone CR | 114 | 331 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Matching | 13 | 337 | |
| other | Vomiting | Gastrointestinal disorders | Tapentadol ER | 32 | 319 | |
| other | Vomiting | Gastrointestinal disorders | Oxycodone CR | 86 | 331 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo Matching | 7 | 337 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Matching | ||
| Total, all-cause mortality | Tapentadol ER | ||
| Total, all-cause mortality | Oxycodone CR | ||
| Total, other adverse events | Placebo Matching | 187 | 337 |
| Total, other adverse events | Tapentadol ER | 214 | 319 |
| Total, other adverse events | Oxycodone CR | 281 | 331 |
| Total, serious adverse events | Placebo Matching | 4 | 337 |
| Total, serious adverse events | Tapentadol ER | 2 | 319 |
| Total, serious adverse events | Oxycodone CR | 13 | 331 |
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/NCT00486811
GET https://conductscience.org/api/trials/v1/NCT00486811/results?page=2