Trial · NCT01529346
Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
NCT01529346, Phase 2, Completed, Pfizer; results first posted 2018-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy Of PF-05089771 In Treating Postoperative Dental Pain. Trials, record NCT01529346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01529346
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Of PF-05089771 In Treating Postoperative Dental Pain
- NCT number
- NCT01529346
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 235 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Postoperative Dental Pain
- Interventions
- PF-05089771, Placebo, PF-05089771, Placebo, PF-05089771, Placebo, Ibuprofen, Placebo, Placebo, Placebo
- First posted
- 2012-02-08
- Last updated
- 2018-06-01
- Results first posted
- 2018-06-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | 0 to 6 hours | TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework. |
| 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 | Pain Relief (PR) Score | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete). |
| Secondary | Pain Intensity Difference (PID) | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | PID was calculated as pain intensity at baseline (baseline pain severity score range 2 \[moderate\] to 3 \[severe\]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 \[none\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). |
| Secondary | Summed Pain Intensity Difference (SPID) | 0 to 6 hours; 0 to 24 hours | SPID: area under the PID effect curve from 0 to 6 hours (SPID\[6\]) and 0 to 24 hours (SPID\[24\]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). |
| Secondary | Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) | 0 to 24 hours | TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate |
| Secondary | Time to Onset of First Perceptible Pain Relief | 0 to 24 hours | Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief. |
| Secondary | Time to Onset of Meaningful Pain Relief | 0 to 24 hours | Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief. |
| Secondary | Time to First Use of Rescue Medication | 0 to 24 hours | Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time. |
| Secondary | Number of Participants With Global Evaluation of Study Medication | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) | Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication\[RM\]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent. |
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 | Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | 0 to 6 hours | Full Analysis Set (FAS): all randomized participants who received at least (\>=) 1 dose of study treatment and had \>=1 evaluable (more than or equal to \[\>=\] 90 minutes post-dose) PR score. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using Last Observation Carried Forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Peak Pain Relief (PPR) | 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | participants | NUMBER |
| SECONDARY | Pain Relief (PR) Score | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference (PID) | 15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Summed Pain Intensity Difference (SPID) | 0 to 6 hours; 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Pain Relief From 0 to 24 Hours (TOTPAR[24]) | 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of First Perceptible Pain Relief | 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | hours | MEDIAN |
| SECONDARY | Time to Onset of Meaningful Pain Relief | 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | hours | MEDIAN |
| SECONDARY | Time to First Use of Rescue Medication | 0 to 24 hours | FAS included all randomized participants who received \>=1 dose of study treatment and had \>=1 evaluable (\>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS. | hours | MEDIAN |
| SECONDARY | Number of Participants With Global Evaluation of Study Medication | 6, 24 hours, prior to rescue medication (assessed up to 24 hours) | FAS: all randomized participants who received \>=1 dose of study treatment, had \>=1 evaluable (\>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure. | participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group465
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | PF-05089771 150 mg | 6.94 | Standard Deviation 0.898 | units on a scale | |
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | PF-05089771 450 mg | 6.21 | Standard Deviation 0.915 | units on a scale | |
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | PF-05089771 1600 mg | 7.00 | Standard Deviation 0.906 | units on a scale | |
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | Ibuprofen | 14.43 | Standard Deviation 1.110 | units on a scale | |
| Total Pain Relief From 0 to 6 Hours (TOTPAR[6]) | Placebo | 4.37 | Standard Deviation 1.082 | units on a scale | |
| Number of Participants With Peak Pain Relief (PPR) | PF-05089771 150 mg | None | 13 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | PF-05089771 450 mg | None | 13 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | PF-05089771 1600 mg | None | 15 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | Ibuprofen | None | 1 | participants | |
| Number of Participants With Peak Pain Relief (PPR) | Placebo | None | 9 | participants |
1 to 10 of 465Source ClinicalTrials.gov
See all 465 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-05089771 150 mg | 55 | |
| Overall Study | STARTED | PF-05089771 450 mg | 54 | |
| Overall Study | STARTED | PF-05089771 1600 mg | 54 | |
| Overall Study | STARTED | Ibuprofen | 36 | |
| Overall Study | STARTED | Placebo | 36 | |
| Overall Study | COMPLETED | PF-05089771 150 mg | 53 | |
| Overall Study | COMPLETED | PF-05089771 450 mg | 53 | |
| Overall Study | COMPLETED | PF-05089771 1600 mg | 52 | |
| Overall Study | COMPLETED | Ibuprofen | 36 | |
| Overall Study | COMPLETED | Placebo | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events65
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 | Abdominal discomfort | Gastrointestinal disorders | PF-05089771 150 mg | 0 | 55 | |
| other | Abdominal discomfort | Gastrointestinal disorders | PF-05089771 450 mg | 2 | 54 | |
| other | Abdominal discomfort | Gastrointestinal disorders | PF-05089771 1600 mg | 0 | 54 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Ibuprofen | 0 | 36 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 36 | |
| other | Constipation | Gastrointestinal disorders | PF-05089771 150 mg | 0 | 55 | |
| other | Constipation | Gastrointestinal disorders | PF-05089771 450 mg | 2 | 54 | |
| other | Constipation | Gastrointestinal disorders | PF-05089771 1600 mg | 0 | 54 | |
| other | Constipation | Gastrointestinal disorders | Ibuprofen | 0 | 36 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 36 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-05089771 150 mg | ||
| Total, all-cause mortality | PF-05089771 450 mg | ||
| Total, all-cause mortality | PF-05089771 1600 mg | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | PF-05089771 150 mg | 16 | 55 |
| Total, other adverse events | PF-05089771 450 mg | 20 | 54 |
| Total, other adverse events | PF-05089771 1600 mg | 23 | 54 |
| Total, other adverse events | Ibuprofen | 10 | 36 |
| Total, other adverse events | Placebo | 12 | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
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