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The purpose of this study is to evaluate the efficacy and safety of single doses of PF-05089771 against placebo in treatment of pain in patients with primary, inherited erythromelalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05089771 1600 mg | Experimental |
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| Placebo comparator: matching placebo | Placebo Comparator | Single oral dose of placebo for PF-05089771 1600 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - 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. | Every 15 minutes from 0 to 4 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Average PI-NRS Score - From Post Evoked Pain Time Point 2 (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. The average pain score was calculated as the mean of the pain scores recorded from EP2 to 8 hours post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27099175 | Derived | Cao L, McDonnell A, Nitzsche A, Alexandrou A, Saintot PP, Loucif AJ, Brown AR, Young G, Mis M, Randall A, Waxman SG, Stanley P, Kirby S, Tarabar S, Gutteridge A, Butt R, McKernan RM, Whiting P, Ali Z, Bilsland J, Stevens EB. Pharmacological reversal of a pain phenotype in iPSC-derived sensory neurons and patients with inherited erythromelalgia. Sci Transl Med. 2016 Apr 20;8(335):335ra56. doi: 10.1126/scitranslmed.aad7653. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A | Participants were exposed to pain stimulus. Reproducibility and repeatability of induced pain attacks and spontaneous reporting of pain by participants was established. Part A was performed for 1-2 days and maximum up to 7 days. Maximum duration between Part A and Part B was of 4 weeks. |
| FG001 | Part B: PF-05089771 Then Placebo Then Placebo Then PF-05089771 | On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of PF-05089771 1600 milligram (mg) on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of placebo matched to PF-05089771, followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months. |
| FG002 | Part B: Placebo Then PF-05089771 Then PF-05089771 Then Placebo | On completion of Part A, participants were randomized in Part B. Part B: Participants were randomized to receive oral dispersion of placebo matched to PF-05089771 on Day 1 of Treatment session 1 (Study Period 1), followed by washout of 72 hours. Then, participants received oral dispersion of PF-05089771 1600 mg on Day 5 of Treatment session 1 (Study Period 2). Treatment session 1 was followed by washout of 72 hours and then Treatment session 2. On Day 1 of Treatment session 2 (Study Period 3), participants received oral dispersion of PF-05089771 1600 mg, followed by washout of 72 hours. Then, participants received oral dispersion of placebo matched to PF-05089771 on Day 5 of Treatment session 2 (Study Period 4). Maximum permitted interval between Study Period 2 completion and the start of Study Period 3 is 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Part A |
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| Part B:Treatment Session1-Period1 |
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| Washout Period |
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| Part B:Treatment Session1-Period2 |
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| Washout Period |
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| Part B:Treatment Session2-Period3 |
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| Washout Period |
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| Part B:Treatment Session2-Period4 |
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Safety set included all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Every 15 minutes from 0 to 4 hours post-dose |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Adverse events were collected only for Part B of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Session 1: PF-05089771 1600 mg | Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C000618268 | PF-05089771 |
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| Placebo | Drug | Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered. |
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| Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose |
| Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (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. The average pain score was calculated as the mean of the pain scores recorded from 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 |
| Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) 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. | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
| Maximum PI-NRS Scores - 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. | From 0 hour to 4 hours post-dose |
| Maximum PI-NRS Scores - 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. | From post EP2 to 8 hours post-dose |
| Maximum PI-NRS Scores - From Post 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. | From the end of EP3 to 10 hours post dose |
| Maximum PI-NRS Scores - From Post EP4 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. | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
| Duration When PI-NRS Scores Were Greater Than (>) 5 - 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. | From 0 hour to 4 hours post-dose |
| Duration When PI-NRS Scores Were >5 - 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. The duration of time that participants experienced PI-NRS score >5 from in period from post EP2 to 8 hours post-dose is reported. | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose |
| Duration When PI-NRS Scores Were >5 - From Post 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. The duration of time that participants experienced PI-NRS score >5 from the 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 |
| Duration When PI-NRS Scores Were >5 - From Post EP4 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. | After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
| Number of Participants With Participant's Global Satisfaction Score | 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. | At 4 hour post-dose or at time of first rescue therapy, whichever occurred first |
| Time to First Use of Rescue Therapy or Medication | 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. | Up to maximum of 24 hours post-dose |
| 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 |
| 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 |
| Maximum Observed Plasma Concentration (Cmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771 | Predose and 0.5, 2, 4, 6, and 24 hours post dose |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline up to a maximum of Day 83 |
| Number of Participants With Laboratory Abnormalities | 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). | Baseline up to a maximum of Day 73 |
| Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature | The minimum starting temperature to measure core body temperature used was 33 degree Celsius. Clinically significant changes from baseline in core body temperature was judged by investigator. | Baseline up to a maximum of Day 83 |
| Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure | Criteria for clinically significant blood pressure abnormalities: systolic blood pressure >=30 millimetre of Mercury (mmHg) change from baseline in same posture, systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline in same posture, diastolic blood pressure <50 mmHg. | Baseline up to a maximum of Day 83 |
| Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) | Criteria for clinically significant abnormalities in ECG : PR interval >=300 millisecond (msec) and 25 percent (%) increase when baseline >200 msec, 50% increase when baseline less than or equal to (<=) 200 msec; QRS interval >=140 msec, >=50% increase from baseline; QT interval >=500 msec; QT interval corrected using the Fridericia formula (QTcF) 450 msec to <480 msec, >=480 msec, 30 to <60 msec increase from baseline, >=60 msec increase from baseline. | Baseline up to a maximum of Day 83 |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 |
| Treatment Session 1: Placebo |
Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1. |
| OG002 | Treatment Session 2: PF-05089771 1600 mg | Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2. |
| OG003 | Treatment Session 2: Placebo | Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2. |
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| Secondary | Average PI-NRS Score - From Post Evoked Pain Time Point 2 (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. The average pain score was calculated as the mean of the pain scores recorded from 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. | Posted | Mean | Standard Deviation | Units on a scale | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose |
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| Secondary | Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (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. The average pain score was calculated as the mean of the pain scores recorded from 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. | Posted | Mean | Standard Deviation | Units on a scale | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose |
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| Secondary | Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
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| Secondary | Maximum PI-NRS Scores - 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | From 0 hour to 4 hours post-dose |
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| Secondary | Maximum PI-NRS Scores - 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | From post EP2 to 8 hours post-dose |
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| Secondary | Maximum PI-NRS Scores - From Post 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | From the end of EP3 to 10 hours post dose |
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| Secondary | Maximum PI-NRS Scores - From Post EP4 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
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| Secondary | Duration When PI-NRS Scores Were Greater Than (>) 5 - 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. | 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. | Posted | Mean | Standard Deviation | Minutes | From 0 hour to 4 hours post-dose |
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| Secondary | Duration When PI-NRS Scores Were >5 - 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. The duration of time that participants experienced PI-NRS score >5 from in period from post EP2 to 8 hours post-dose is reported. | 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. | Posted | Mean | Standard Deviation | Minutes | Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose |
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| Secondary | Duration When PI-NRS Scores Were >5 - From Post 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. The duration of time that participants experienced PI-NRS score >5 from the post 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. | Posted | Mean | Standard Deviation | Minutes | Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose |
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| Secondary | Duration When PI-NRS Scores Were >5 - From Post EP4 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. | 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. | Posted | Mean | Standard Deviation | Minutes | After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose |
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| Secondary | Number of Participants With Participant's Global Satisfaction Score | 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. | 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. | Posted | Count of Participants | Participants | At 4 hour post-dose or at time of first rescue therapy, whichever occurred first |
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| Secondary | Time to First Use of Rescue Therapy or Medication | 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. | 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. | Posted | Mean | 90% Confidence Interval | Hours | Up to maximum of 24 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter (ng*hr/mL) | Predose, 0.5, 2, 4, 6, and 24 hours post-dose |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter (ng*hr/mL) | Predose and 0.5, 2, 4, 6, and 24 hours post dose |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05089771 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | Predose and 0.5, 2, 4, 6, and 24 hours post dose |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771 | 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. | Posted | Median | Full Range | Hours | Predose and 0.5, 2, 4, 6, and 24 hours post dose |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to a maximum of Day 83 |
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| Secondary | Number of Participants With Laboratory Abnormalities | 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). | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to a maximum of Day 73 |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature | The minimum starting temperature to measure core body temperature used was 33 degree Celsius. Clinically significant changes from baseline in core body temperature was judged by investigator. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to a maximum of Day 83 |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure | Criteria for clinically significant blood pressure abnormalities: systolic blood pressure >=30 millimetre of Mercury (mmHg) change from baseline in same posture, systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline in same posture, diastolic blood pressure <50 mmHg. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to a maximum of Day 83 |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) | Criteria for clinically significant abnormalities in ECG : PR interval >=300 millisecond (msec) and 25 percent (%) increase when baseline >200 msec, 50% increase when baseline less than or equal to (<=) 200 msec; QRS interval >=140 msec, >=50% increase from baseline; QT interval >=500 msec; QT interval corrected using the Fridericia formula (QTcF) 450 msec to <480 msec, >=480 msec, 30 to <60 msec increase from baseline, >=60 msec increase from baseline. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to a maximum of Day 83 |
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| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Treatment Session 1: Placebo | Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 1. | 0 | 5 | 5 | 5 |
| EG002 | Treatment Session 2: PF-05089771 1600 mg | Participants received oral dispersion of PF-05089771 1600 mg in Treatment session 2. | 0 | 5 | 5 | 5 |
| EG003 | Treatment Session 2: Placebo | Participants received oral dispersion of placebo matched to PF-05089771 in Treatment session 2. | 0 | 5 | 4 | 5 |
| Chapped lips | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Feeling cold | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA version 16.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 16.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Fair Score |
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| Good Score |
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| Excellent Score |
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| Other |
| SAEs |
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