Trial · NCT00913627
Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
NCT00913627, Phase 2, Completed, Pfizer; results first posted 2018-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain. Trials, record NCT00913627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00913627
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
- NCT number
- NCT00913627
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 196 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pain
- Interventions
- ibuprofen, ibuprofen, naproxen, Placebo
- First posted
- 2009-06-04
- Last updated
- 2018-03-22
- Results first posted
- 2018-03-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Baseline (0 hour) to 12 hours post dose | Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity). |
| Primary | Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 8 to 12 hours post dose | PID score based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity). |
| Secondary | Time to First Perceptible Pain Relief | Baseline to 6 hours | Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled "first perceptible relief", if the participant also depressed the second stopwatch labelled as "meaningful relief" by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently. |
| Secondary | Time to Treatment Failure | Baseline to 24 hours | Time to first rescue medication or discontinuation due to lack of efficacy |
| Secondary | Percentage of Participants With Treatment Failure | 8, 9, 10, 11, and 12 hours | Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy. |
| Secondary | Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) | 0 to 4 hours and 4 to 8 hours | Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, "How much pain do you have at this time?" Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity). |
| Secondary | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement. |
| Secondary | Time-weighted Sum of Pain Relief Scores (TOTPAR) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | TOTPAR based on 5-point categorical pain relief scale. Participants asked, "How much relief do you have from your starting pain?" Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best). |
| Secondary | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes | The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now. |
| Secondary | Time to Meaningful Pain Relief | Baseline to 6 hours | Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant. |
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 | Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Baseline (0 hour) to 12 hours post dose | Intent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment. | units on a scale | MEAN |
| PRIMARY | Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | 8 to 12 hours post dose | ITT population | units on a scale | MEAN |
| SECONDARY | Time to First Perceptible Pain Relief | Baseline to 6 hours | ITT population | minutes | MEDIAN |
| SECONDARY | Time to Treatment Failure | Baseline to 24 hours | ITT population | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Failure | 8, 9, 10, 11, and 12 hours | ITT population | percentage of participants | NUMBER |
| SECONDARY | Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8) | 0 to 4 hours and 4 to 8 hours | ITT population | units on a scale | MEAN |
| SECONDARY | Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | ITT population | units on a scale | MEAN |
| SECONDARY | Time-weighted Sum of Pain Relief Scores (TOTPAR) | 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours | ITT population | units on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief | 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes | ITT population | percentage of participants | NUMBER |
| SECONDARY | Time to Meaningful Pain Relief | Baseline to 6 hours | ITT population | minutes | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group452
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 Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Placebo | 0.05 | Standard Deviation 9.22 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Ibuprofen IR/ER (Roller Compaction) | 16.87 | Standard Deviation 9.35 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Ibuprofen IR/ER (Wet Granulation) | 17.34 | Standard Deviation 10.54 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12) | Naproxen | 12.66 | Standard Deviation 10.02 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | Placebo | -0.03 | Standard Deviation 4.05 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | Ibuprofen IR/ER (Roller Compaction) | 6.57 | Standard Deviation 4.44 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | Ibuprofen IR/ER (Wet Granulation) | 7.14 | Standard Deviation 5.24 | units on a scale | |
| Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12) | Naproxen | 5.14 | Standard Deviation 5.02 | units on a scale | |
| Time to First Perceptible Pain Relief | Placebo | NA | 95% Confidence Interval NA to NA | minutes | |
| Time to First Perceptible Pain Relief | Ibuprofen IR/ER (Roller Compaction) | 29.4 | 95% Confidence Interval 23.3 to 35.3 | minutes |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 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 | 29 | |
| Overall Study | STARTED | Ibuprofen IR/ER (Roller Compaction) | 53 | |
| Overall Study | STARTED | Ibuprofen IR/ER (Wet Granulation) | 56 | |
| Overall Study | STARTED | Naproxen | 58 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | COMPLETED | Ibuprofen IR/ER (Roller Compaction) | 53 | |
| Overall Study | COMPLETED | Ibuprofen IR/ER (Wet Granulation) | 56 | |
| Overall Study | COMPLETED | Naproxen | 58 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Ibuprofen IR/ER (Roller Compaction) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
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 | Eye swelling | Eye disorders | Placebo | 0 | 29 | |
| other | Eye swelling | Eye disorders | Ibuprofen IR/ER (Roller Compaction) | 0 | 53 | |
| other | Eye swelling | Eye disorders | Ibuprofen IR/ER (Wet Granulation) | 0 | 56 | |
| other | Eye swelling | Eye disorders | Naproxen | 1 | 58 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 29 | |
| other | Nausea | Gastrointestinal disorders | Ibuprofen IR/ER (Roller Compaction) | 1 | 53 | |
| other | Nausea | Gastrointestinal disorders | Ibuprofen IR/ER (Wet Granulation) | 5 | 56 | |
| other | Nausea | Gastrointestinal disorders | Naproxen | 2 | 58 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 5 | 29 | |
| other | Vomiting | Gastrointestinal disorders | Ibuprofen IR/ER (Roller Compaction) | 0 | 53 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 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 | Ibuprofen IR/ER (Roller Compaction) | ||
| Total, all-cause mortality | Ibuprofen IR/ER (Wet Granulation) | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | Placebo | 8 | 29 |
| Total, other adverse events | Ibuprofen IR/ER (Roller Compaction) | 3 | 53 |
| Total, other adverse events | Ibuprofen IR/ER (Wet Granulation) | 8 | 56 |
| Total, other adverse events | Naproxen | 6 | 58 |
| Total, serious adverse events | Placebo | 0 | 29 |
| Total, serious adverse events | Ibuprofen IR/ER (Roller Compaction) | 0 | 53 |
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/NCT00913627
GET https://conductscience.org/api/trials/v1/NCT00913627/results?page=2