Trial · NCT01769274
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose | Every 15 minutes from 0 to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose | From post EP2 to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose | From the end of EP3 to 10 hours post dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Minutes | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were >5 - From Post EP3 to 10 Hours Post-dose | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Duration When PI-NRS Scores Were >5 - From Post EP4 to 28 Hours Post-dose | After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. | Minutes | MEAN |
| SECONDARY | Number of Participants With Participant's Global Satisfaction Score | At 4 hour post-dose or at time of first rescue therapy, whichever occurred first | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Use of Rescue Therapy or Medication | Up to maximum of 24 hours post-dose | Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Number of Participants Analyzed = number of participants evaluable for this outcome measure. | Hours | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771 | Predose, 0.5, 2, 4, 6, and 24 hours post-dose | Pharmacokinetic (PK) parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session. | Nanogram*hour per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose | PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session. | Nanogram*hour per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose | PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session. | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose | PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session. | Hours | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to a maximum of Day 83 | Safety analysis set included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Baseline up to a maximum of Day 73 | Safety analysis set included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01769274/outcomes