Trial · NCT00613938
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
NCT00613938, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-04-23
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) in the Treatment of Acute Pain From Bunionectomy. Trials, record NCT00613938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00613938
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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) in the Treatment of Acute Pain From Bunionectomy.
- NCT number
- NCT00613938
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 901 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Arthralgia, Bunion, Hallux Valgus, Pain
- Interventions
- Tapentadol (CG5503), Tapentadol (CG5503), oxycodone, placebo
- First posted
- 2008-02-13
- Last updated
- 2014-05-09
- Results first posted
- 2010-04-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sum of Pain Intensity Difference Over 48 Hours (SPID48) | 48 hours | The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. |
| Secondary | Time to First Rescue Pain Medication Use. | 3 days | The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication. |
| Secondary | The SPID at 12 Hours Relative to First Dose. | 12 hours | The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. |
| Secondary | SPID at 24 Hours Relative to First Dose | 24 hours | The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. |
| Secondary | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3 | Baseline and 3 days | Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3 |
| Secondary | Total Pain Relief (TOTPAR)at 48 Hours | 48 hours | Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference Over 48 Hours (SPID48) | 48 hours | The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score. | Scores on a scale | MEAN |
| SECONDARY | Time to First Rescue Pain Medication Use. | 3 days | The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score. | ||
| SECONDARY | The SPID at 12 Hours Relative to First Dose. | 12 hours | The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score. | Scores on a scale | MEAN |
| SECONDARY | SPID at 24 Hours Relative to First Dose | 24 hours | The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score. | Scores on a scale | MEAN |
| SECONDARY | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3 | Baseline and 3 days | The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score. | percentage of participants | NUMBER |
| SECONDARY | Total Pain Relief (TOTPAR)at 48 Hours | 48 hours | Intent-to-treat | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sum of Pain Intensity Difference Over 48 Hours (SPID48) | Placebo | 54.1 | Standard Deviation 105.74 | Scores on a scale | |
| Sum of Pain Intensity Difference Over 48 Hours (SPID48) | Tapentadol 50mg Fixed Dose | 122.2 | Standard Deviation 98.66 | Scores on a scale | |
| Sum of Pain Intensity Difference Over 48 Hours (SPID48) | Tapentadol 75mg Fixed Dose | 143.7 | Standard Deviation 96.52 | Scores on a scale | |
| Sum of Pain Intensity Difference Over 48 Hours (SPID48) | Oxycodone 10mg Fixed Dose | 140.3 | Standard Deviation 99.52 | Scores on a scale | |
| The SPID at 12 Hours Relative to First Dose. | Placebo | 7.5 | Standard Deviation 20.7 | Scores on a scale | |
| The SPID at 12 Hours Relative to First Dose. | Tapentadol 50mg Fixed Dose | 21.1 | Standard Deviation 21.89 | Scores on a scale | |
| The SPID at 12 Hours Relative to First Dose. | Tapentadol 75mg Fixed Dose | 26.0 | Standard Deviation 23.11 | Scores on a scale | |
| The SPID at 12 Hours Relative to First Dose. | Oxycodone 10mg Fixed Dose | 24.9 | Standard Deviation 22.8 | Scores on a scale | |
| SPID at 24 Hours Relative to First Dose | Placebo | 12.1 | Standard Deviation 43.64 | Scores on a scale | |
| SPID at 24 Hours Relative to First Dose | Tapentadol 50mg Fixed Dose | 45.4 | Standard Deviation 45.73 | Scores on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 69 | |
| Overall Study | STARTED | Tapentadol 50mg Fixed Dose | 275 | |
| Overall Study | STARTED | Tapentadol 75mg Fixed Dose | 278 | |
| Overall Study | STARTED | Oxycodone 10mg Fixed Dose | 279 | |
| Overall Study | COMPLETED | Placebo | 49 | |
| Overall Study | COMPLETED | Tapentadol 50mg Fixed Dose | 247 | |
| Overall Study | COMPLETED | Tapentadol 75mg Fixed Dose | 255 | |
| Overall Study | COMPLETED | Oxycodone 10mg Fixed Dose | 253 | |
| Overall Study | NOT COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Tapentadol 50mg Fixed Dose | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Alanine aminotransferase increased | Investigations | Placebo | 1 | 69 | |
| other | Alanine aminotransferase increased | Investigations | Tapentadol 50mg Fixed Dose | 8 | 275 | |
| other | Alanine aminotransferase increased | Investigations | Tapentadol 75mg Fixed Dose | 7 | 278 | |
| other | Alanine aminotransferase increased | Investigations | Oxycodone 10mg Fixed Dose | 14 | 279 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 69 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol 50mg Fixed Dose | 22 | 275 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol 75mg Fixed Dose | 15 | 278 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone 10mg Fixed Dose | 31 | 279 | |
| other | Dizziness | Nervous system disorders | Placebo | 7 | 69 | |
| other | Dizziness | Nervous system disorders | Tapentadol 50mg Fixed Dose | 41 | 275 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Tapentadol 50mg Fixed Dose | ||
| Total, all-cause mortality | Tapentadol 75mg Fixed Dose | ||
| Total, all-cause mortality | Oxycodone 10mg Fixed Dose | ||
| Total, other adverse events | Placebo | 25 | 69 |
| Total, other adverse events | Tapentadol 50mg Fixed Dose | 161 | 275 |
| Total, other adverse events | Tapentadol 75mg Fixed Dose | 192 | 278 |
| Total, other adverse events | Oxycodone 10mg Fixed Dose | 218 | 279 |
| Total, serious adverse events | Placebo | 0 | 69 |
| Total, serious adverse events | Tapentadol 50mg Fixed Dose | 0 | 275 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19445652 | DERIVED |
Source PubMed
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/NCT00613938
GET https://conductscience.org/api/trials/v1/NCT00613938/events?page=2