Trial · NCT01769274
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP2 to 8 hours post-dose. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP3 to 10 hours post-dose. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP4 to 28 hours post-dose. |
| Secondary | Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose | From 0 hour to 4 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Maximum pain score in 4 hours period post-dosing is reported. |
| Secondary | Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose | From post EP2 to 8 hours post-dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. Maximum pain score in period from post EP2 to 8 hours post-dose is reported. |
| Secondary | Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose | From the end of EP3 to 10 hours post dose | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. Maximum pain score in period from post EP3 to 10 hours post-dose is reported. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. Maximum pain score in period from post EP4 to 28 hours post-dose is reported. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. The duration of time that participants experienced PI-NRS score greater than 5 from the 0 hours to 4 hours post-dose. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from in period from post EP2 to 8 hours post-dose is reported. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from the post EP3 to 10 hours post dose. |
| 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 | Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The duration of time that participants experienced PI-NRS score \>5 from post EP4 to 28 hours post-dose. |
| 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 | Participant was asked "How would you rate the study medication you received for pain?". The participant was provided the following choices as an answer: excellent=4; good=3; fair=2; poor=1. Response to this question, was participant's overall impression (global evaluation) of the study medication at 4 hour post-dose or at time of first rescue treatment or medication, which ever occurred first. |
| Secondary | Time to First Use of Rescue Therapy or Medication | Up to maximum of 24 hours post-dose | Time to rescue medication (hour) was calculated as: date/time of rescue medication minus date/time of first dose for each period. If participant who did not receive rescue medication, the time of censoring was cut off at 24 hours or the time of withdrawal, whichever was earlier. Kaplan-Meier method was used for estimation. |
| 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 | |
| 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 | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to a maximum of Day 83 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. |
| Secondary | Number of Participants With Laboratory Abnormalities | Baseline up to a maximum of Day 73 | Laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell count: less than(\<)0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN/greater than (\>)1.75\*upper limit of normal (ULN), white blood cell: \<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil (absolute, %):\<0.8\*LLN/\>1.2\*ULN, total neutrophil \<0.8\*LLN;basophil, eosinophil, monocyte (absolute, %):\>1.2\*ULN; mean corpuscular (MC) volume, mean cell hemoglobin, MC hemoglobin concentration, mean platelet volume: \<0.9\*LLN/\>1.1\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN/\>1.2\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN, uric acid \>1.2\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN/\>1.1\*ULN; glucose \<0.6\*LLN/\>1.5\*ULN; urine (specific gravity \<1.003/\>1.030, pH \<4.5/\>8, glucose, ketone, protein, blood/Hgb, urobilinogen, bilirubin, nitrite, leukocyte esterase \>=1). |
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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