Trial · NCT01512160
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
NCT01512160, Phase 2, Terminated, Pfizer; results first posted 2013-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain. Trials, record NCT01512160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01512160
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
- NCT number
- NCT01512160
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Post-surgical Dental Pain
- Interventions
- PF-04531083, Placebo, PF-04531083, Placebo, Ibuprofen, Placebo, Placebo, Placebo
- First posted
- 2012-01-19
- Last updated
- 2013-06-28
- Results first posted
- 2013-06-28
- Limitations and caveats
- Study was terminated for futility based on results of interim analysis.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | 0 to 6 hours | TOTPAR \[6\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \[6\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR. |
| Secondary | Number of Participants With Peak Pain Relief (PPR) | 0 to 24 hours | PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). |
| Secondary | Time-specific Pain Relief (PR) Score | 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM) | PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points. |
| Secondary | Time-specific Pain Intensity Difference (PID) Score | 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM | Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. |
| Secondary | Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours | 0 to 6, 0 to 24 hours | Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief. |
| Secondary | Total Pain Relief (TOTPAR) Score From 0 to 24 Hours | 0 to 24 hours | TOTPAR \[24\] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR \[24\]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR. |
| Secondary | Time to Onset of First Perceptible Pain Relief (PR) | 0 to 24 hours | Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. |
| Secondary | Time to Onset of First Meaningful Pain Relief (PR) | 0 to 24 hours | Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. |
| Secondary | Time to First Use of Rescue Medication | 1.5 to 24 hours | Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time. |
| Secondary | Number of Participants With Rescue Medication | 0 to 24 hours | Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | 0 to 6 hours | Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF). | units on a scale*hour | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Peak Pain Relief (PPR) | 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. | participants | NUMBER |
| SECONDARY | Time-specific Pain Relief (PR) Score | 0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM) | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point. | units on a scale | MEAN |
| SECONDARY | Time-specific Pain Intensity Difference (PID) Score | 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point. | units on a scale | MEAN |
| SECONDARY | Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours | 0 to 6, 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF. | units on a scale*hour | LEAST_SQUARES_MEAN |
| SECONDARY | Total Pain Relief (TOTPAR) Score From 0 to 24 Hours | 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF. | units on a scale*hour | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of First Perceptible Pain Relief (PR) | 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. | hours | MEDIAN |
| SECONDARY | Time to Onset of First Meaningful Pain Relief (PR) | 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. | hours | MEDIAN |
| SECONDARY | Time to First Use of Rescue Medication | 1.5 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. | hours | MEDIAN |
| SECONDARY | Number of Participants With Rescue Medication | 0 to 24 hours | FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. | participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group524
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | PF-04531083 1000 mg | 4.3 | Standard Error 1.5 | units on a scale*hour | |
| Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | PF-04531083 2000 mg | 4.4 | Standard Error 1.5 | units on a scale*hour | |
| Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | Ibuprofen 400 mg | 8.8 | Standard Error 1.5 | units on a scale*hour | |
| Total Pain Relief (TOTPAR) Score From 0 to 6 Hours | Placebo | 5.3 | Standard Error 1.5 | units on a scale*hour | |
| Number of Participants With Peak Pain Relief (PPR) | PF-04531083 1000 mg | None | 4 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | PF-04531083 2000 mg | None | 3 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | Ibuprofen 400 mg | None | 3 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | Placebo | None | 4 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | PF-04531083 1000 mg | A Little | 4 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | PF-04531083 2000 mg | A Little | 6 | participants |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-04531083 1000 mg | 22 | |
| Overall Study | STARTED | PF-04531083 2000 mg | 23 | |
| Overall Study | STARTED | Ibuprofen 400 mg | 22 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | PF-04531083 1000 mg | 20 | |
| Overall Study | COMPLETED | PF-04531083 2000 mg | 23 | |
| Overall Study | COMPLETED | Ibuprofen 400 mg | 22 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | PF-04531083 1000 mg | 2 | |
| Overall Study | NOT COMPLETED | PF-04531083 2000 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
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 | PF-04531083 1000 mg | 4 | 22 | |
| other | Nausea | Gastrointestinal disorders | PF-04531083 2000 mg | 3 | 23 | |
| other | Nausea | Gastrointestinal disorders | Ibuprofen 400 mg | 3 | 22 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 23 | |
| other | Vomiting | Gastrointestinal disorders | PF-04531083 1000 mg | 2 | 22 | |
| other | Vomiting | Gastrointestinal disorders | PF-04531083 2000 mg | 0 | 23 | |
| other | Vomiting | Gastrointestinal disorders | Ibuprofen 400 mg | 1 | 22 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 23 | |
| other | Tooth infection | Infections and infestations | PF-04531083 1000 mg | 3 | 22 | |
| other | Tooth infection | Infections and infestations | PF-04531083 2000 mg | 0 | 23 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-04531083 1000 mg | ||
| Total, all-cause mortality | PF-04531083 2000 mg | ||
| Total, all-cause mortality | Ibuprofen 400 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | PF-04531083 1000 mg | 13 | 22 |
| Total, other adverse events | PF-04531083 2000 mg | 10 | 23 |
| Total, other adverse events | Ibuprofen 400 mg | 8 | 22 |
| Total, other adverse events | Placebo | 5 | 23 |
| Total, serious adverse events | PF-04531083 1000 mg | 0 | 22 |
| Total, serious adverse events | PF-04531083 2000 mg | 0 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 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/NCT01512160
GET https://conductscience.org/api/trials/v1/NCT01512160/registered?page=2