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Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
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Trial · NCT00913627

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 17 of 17

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TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)Baseline (0 hour) to 12 hours post doseIntent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment.units on a scaleMEAN
PRIMARYTime-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)8 to 12 hours post doseITT populationunits on a scaleMEAN
SECONDARYTime to First Perceptible Pain ReliefBaseline to 6 hoursITT populationminutesMEDIAN
SECONDARYTime to Treatment FailureBaseline to 24 hoursITT populationhoursMEDIAN
SECONDARYPercentage of Participants With Treatment Failure8, 9, 10, 11, and 12 hoursITT populationpercentage of participantsNUMBER
SECONDARYTime-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 hoursITT populationunits on a scaleMEAN
SECONDARYTime-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 hoursITT populationunits on a scaleMEAN
SECONDARYTime-weighted Sum of Pain Relief Scores (TOTPAR)0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hoursITT populationunits on a scaleMEAN
SECONDARYPercentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutesITT populationpercentage of participantsNUMBER
SECONDARYTime to Meaningful Pain ReliefBaseline to 6 hoursITT populationminutesMEDIAN
SECONDARYPercentage of Participants Achieving Meaningful Pain Relief15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutesITT populationpercentage of participantsNUMBER
SECONDARYParticipant Global Evaluation of Study Medication at 12 Hours12 hoursITT populationparticipantsNUMBER
SECONDARYParticipant Global Evaluation of Study Medication at 24 Hours24 hoursITT population; Number of participants analyzed (N)= participants with evaluable dataparticipantsNUMBER
SECONDARYPain Intensity Difference (PID) Score15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hoursITT population.units on a scaleMEAN
SECONDARYPain Relief (PR) Score15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hoursITT population.units on a scaleMEAN
SECONDARYPain Relief Combined With Pain Intensity Difference (PRID) Score15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hoursITT population.units on a scaleMEAN
SECONDARYPeak Pain Relief ScoreBaseline to 12 hoursITT populationunits on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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