Trial · NCT01929031
Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain
NCT01929031, Phase 3, Completed, Boehringer Ingelheim; results first posted 2016-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain. Trials, record NCT01929031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01929031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain
- NCT number
- NCT01929031
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 562 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pain, Postoperative, Tooth Diseases
- Interventions
- ibuprofen + caffeine, ibuprofen, ibuprofen, caffeine, ibuprofen + caffeine, placebo, placebo, caffeine, ibuprofen, ibuprofen + caffeine
- First posted
- 2013-08-27
- Last updated
- 2016-11-16
- Results first posted
- 2016-11-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | 0 to 8 hours | SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours. |
| Secondary | Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | 0 to 2 hours | SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours. |
| Secondary | Duration of Pain Relief | 8 hours | Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours. |
| Secondary | Time to Meaningful Pain Relief | 8 hours | Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours. |
Source ClinicalTrials.gov
Outcomes4
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 (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | 0 to 8 hours | Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | 0 to 2 hours | Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Pain Relief | 8 hours | Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS) | hours | MEDIAN |
| SECONDARY | Time to Meaningful Pain Relief | 8 hours | Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS) | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group16
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 (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | Placebo | 10.554 | Standard Error 3.527 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | Caffeine | 15.824 | Standard Error 3.525 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | Ibuprofen | 40.165 | Standard Error 2.047 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) | Ibuprofen/Caffeine | 52.291 | Standard Error 2.027 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | Placebo | 2.059 | Standard Error 0.703 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | Caffeine | 2.612 | Standard Error 0.702 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | Ibuprofen | 6.990 | Standard Error 0.408 | units on a scale | |
| Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h) | Ibuprofen/Caffeine | 10.584 | Standard Error 0.404 | units on a scale | |
| Duration of Pain Relief | Placebo | 1.63 | 95% Confidence Interval 1.60 to 2.07 | hours | |
| Duration of Pain Relief | Caffeine | 2.08 | 95% Confidence Interval 1.67 to 3.83 | hours |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen/Caffeine - Ibuprofen/Caffeine | 213 | |
| Overall Study | STARTED | Ibuprofen - Ibuprofen | 209 | |
| Overall Study | STARTED | Caffeine - Ibuprofen/Caffeine | 35 | |
| Overall Study | STARTED | Caffeine - Ibuprofen | 35 | |
| Overall Study | STARTED | Placebo - Ibuprofen/Caffeine | 34 | |
| Overall Study | STARTED | Placebo - Ibuprofen | 36 | |
| Overall Study | COMPLETED | Ibuprofen/Caffeine - Ibuprofen/Caffeine | 209 | |
| Overall Study | COMPLETED | Ibuprofen - Ibuprofen | 207 | |
| Overall Study | COMPLETED | Caffeine - Ibuprofen/Caffeine | 34 | |
| Overall Study | COMPLETED | Caffeine - Ibuprofen | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
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 | 3 | 70 | |
| other | Nausea | Gastrointestinal disorders | Caffeine | 1 | 70 | |
| other | Nausea | Gastrointestinal disorders | Ibuprofen | 9 | 279 | |
| other | Nausea | Gastrointestinal disorders | Ibuprofen/Caffeine | 23 | 282 | |
| serious | Oral infection | Infections and infestations | Placebo | 0 | 70 | |
| serious | Oral infection | Infections and infestations | Caffeine | 0 | 70 | |
| serious | Oral infection | Infections and infestations | Ibuprofen | 1 | 279 | |
| serious | Oral infection | Infections and infestations | Ibuprofen/Caffeine | 0 | 282 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Caffeine | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, all-cause mortality | Ibuprofen/Caffeine | ||
| Total, other adverse events | Placebo | 3 | 70 |
| Total, other adverse events | Caffeine | 1 | 70 |
| Total, other adverse events | Ibuprofen | 9 | 279 |
| Total, other adverse events | Ibuprofen/Caffeine | 23 | 282 |
| Total, serious adverse events | Placebo | 0 | 70 |
| Total, serious adverse events | Caffeine | 0 | 70 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT01929031
GET https://conductscience.org/api/trials/v1/NCT01929031/registered