Trial · NCT01075243
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Every two hours from Baseline to 6 hours post dose | Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. | Score on a scale | MEAN |
| SECONDARY | Time to Confirmed First Perceptible Relief | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | minutes | MEAN |
| SECONDARY | Time to Onset of Meaningful Pain Relief | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | minutes | MEAN |
| SECONDARY | Time to Start Using Rescue Medication | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored. | minutes | MEDIAN |
| SECONDARY | Percentage of Participants Who Took Rescue Medication at 2 Hours | Baseline to 2 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Took Rescue Medication at 6 Hours | Baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Percentage of participants | NUMBER |
| SECONDARY | SPRID at 2 Hours | Every two hours from baseline to 2 hours post dose | All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | SPRID at 4 Hours | Every two hours from baseline to 4 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | Total Pain Relief Score (TOTPAR) at 2 Hours | Every two hours from baseline to 2 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | TOTPAR at 4 Hours | Every two hours from baseline to 4 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | TOTPAR at 6 Hours | Every two hours from baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | Every two hours from baseline to 2 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | SPID Scores at 4 Hours | Every two hours from baseline to 4 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | SPID Scores at 6 Hours | Every two hours from baseline to 6 hours post dose | ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes. | Score on a scale | MEAN |
| SECONDARY | Participants Global Assessment to Response to Treatment (PGART) | Baseline to 6 hours post dose | ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment. | Score on a scale | 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/NCT01075243/outcomes