Trial · NCT01048866
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | baseline (pre-dose), post-dose - hourly up to 24 hours | Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded \>= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint. | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), Hours 1 and 2 post-dose | Intent to treat population of participants who took the first full dose of medication | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), hourly readings to 2 hours post-dose | Intent to treat population of participants who took the first full dose of medication | units on a scale | MEAN |
| SECONDARY | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | baseline (pre-dose), post-dose: 1 hour, 2 hours | Intent to treat population | units on a scale | MEAN |
| SECONDARY | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe | baseline (pre-dose), 24 hours post dose (measured each hour post dose) | Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline. | units on a scale | MEAN |
| SECONDARY | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | 2 hours | Intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | 24 hours | Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo). | percentage of participants | NUMBER |
| SECONDARY | Participant Satisfaction Score 24 Hours After Initial Dose | 24 hours | Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score. | percentage of participants | NUMBER |
| SECONDARY | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Day 7 (end of study) | Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant. | percentage of participants | NUMBER |
| SECONDARY | Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2) | Days 2-7 | Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2) | Days 2-7 | Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2) | Days 2-7 | Intent to treat population of participants who were active in the study on day 2 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Days 2-7 | Intent to treat population of participants who were active in the study on day 2 | percentage of doses | NUMBER |
| SECONDARY | Percentage of Participants Who Took Rescue Pain Medication | Days 1-7 | Intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Time to First Rescue Pain Medication | Days 1-7 | Intent to treat population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Temperature at 2 Hours Post Initial Dose | baseline (pre-dose), 2 hours post-dose | Safety population | degrees Fahrenheit | MEAN |
| SECONDARY | Change From Baseline in Body Temperature at End of Study | baseline (pre-dose), up to Day 7 | Safety population of participants with a recording at the end of study visit. | degrees Fahrenheit | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01048866/outcomes