Trial · NCT02863575
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
NCT02863575, Phase 3, Completed, Pfizer; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine. Trials, record NCT02863575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02863575
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
- NCT number
- NCT02863575
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 374 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pain
- Interventions
- Ibuprofen/Caffeine, Ibuprofen, Placebo
- First posted
- 2016-08-11
- Last updated
- 2019-04-08
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | From 0 to 8 hours post-dose on Day 1 | SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain. |
| Secondary | Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain. |
| Secondary | Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain. |
| Secondary | Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain. |
| Secondary | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1 | PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain. |
| Secondary | Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 | PRR score: at each post-dose time point participants answered to a question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. |
| Secondary | Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 | NPSR scale: at baseline and each post-dose time point participants answered to a question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain. |
| Secondary | Time to Onset of Achieving Meaningful Relief | Up to 8 hours post-dose on Day 1 | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "meaningful relief" at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). |
| Secondary | Time to Onset of First Perceptible Relief | Up to 8 hours post-dose on Day 1 | When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as "first perceptible relief" and another as "meaningful relief." Participants were instructed to stop the stopwatch labelled as "first perceptible relief" at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered). |
| Secondary | Time to Treatment Failure | Up to 8 hours post dose on Day 1 | Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | From 0 to 8 hours post-dose on Day 1 | Full analysis set (FAS) population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) | From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose | 0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Onset of Achieving Meaningful Relief | Up to 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | minutes | MEDIAN |
| SECONDARY | Time to Onset of First Perceptible Relief | Up to 8 hours post-dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | minutes | MEDIAN |
| SECONDARY | Time to Treatment Failure | Up to 8 hours post dose on Day 1 | FAS population included all randomized participants who received study medication and provided a baseline assessment. | minutes | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | Ibuprofen 400 mg + Caffeine 100 mg | 55.5 | Standard Error 1.8 | units on a scale | |
| Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen | Ibuprofen 400 mg | 52.8 | Standard Error 1.8 | units on a scale | |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg + Caffeine 100 mg | SPRID 0-2 | 13.3 | Standard Error 0.4 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg | SPRID 0-2 | 12.2 | Standard Error 0.4 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Placebo | SPRID 0-2 | 2.2 | Standard Error 0.7 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg + Caffeine 100 mg | SPRID 0-4 | 30.0 | Standard Error 0.8 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg | SPRID 0-4 | 28.5 | Standard Error 0.8 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Placebo | SPRID 0-4 | 6.0 | Standard Error 1.5 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg + Caffeine 100 mg | SPRID 0-6 | 44.5 | Standard Error 1.3 | units on a scale |
| Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) | Ibuprofen 400 mg | SPRID 0-6 | 42.1 | Standard Error 1.3 | units on a scale |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen 400 mg + Caffeine 100 mg | 161 | |
| Overall Study | STARTED | Ibuprofen 400 mg | 161 | |
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | COMPLETED | Ibuprofen 400 mg + Caffeine 100 mg | 160 | |
| Overall Study | COMPLETED | Ibuprofen 400 mg | 159 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | Ibuprofen 400 mg + Caffeine 100 mg | 1 | |
| Overall Study | NOT COMPLETED | Ibuprofen 400 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events87
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 | Gilbert's syndrome | Congenital, familial and genetic disorders | Ibuprofen 400 mg + Caffeine 100 mg | 0 | 161 | |
| other | Gilbert's syndrome | Congenital, familial and genetic disorders | Ibuprofen 400 mg | 1 | 161 | |
| other | Gilbert's syndrome | Congenital, familial and genetic disorders | Placebo | 0 | 52 | |
| other | Vision blurred | Eye disorders | Ibuprofen 400 mg + Caffeine 100 mg | 0 | 161 | |
| other | Vision blurred | Eye disorders | Ibuprofen 400 mg | 1 | 161 | |
| other | Vision blurred | Eye disorders | Placebo | 0 | 52 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Ibuprofen 400 mg + Caffeine 100 mg | 0 | 161 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Ibuprofen 400 mg | 1 | 161 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Placebo | 0 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | Ibuprofen 400 mg + Caffeine 100 mg | 1 | 161 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen 400 mg + Caffeine 100 mg | 0 | 161 |
| Total, all-cause mortality | Ibuprofen 400 mg | 0 | 161 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, other adverse events | Ibuprofen 400 mg + Caffeine 100 mg | 15 | 161 |
| Total, other adverse events | Ibuprofen 400 mg | 15 | 161 |
| Total, other adverse events | Placebo | 8 | 52 |
| Total, serious adverse events | Ibuprofen 400 mg + Caffeine 100 mg | 0 | 161 |
| Total, serious adverse events | Ibuprofen 400 mg | 0 | 161 |
| Total, serious adverse events | Placebo | 0 | 52 |
Source ClinicalTrials.gov
Papers0
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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