Phase 2 N=5 Randomized Double-blind Treatment

Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia

Inherited Erythromelalgia

Bottom Line

View on ClinicalTrials.gov: NCT01769274 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose — 2.08; 2.73; 1.95; 2.04 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-05089771 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose	2.08; 2.73; 1.95; 2.04	—
SECONDARY Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose	0.70; 0.61; 0.55; 1.08	—
SECONDARY Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose	1.19; 1.55; 0.82; 1.39	—
SECONDARY Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose	0.99; 0.91; 0.36; 0.77	—
SECONDARY Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose	7.6; 8.0; 8.2; 8.6	—
SECONDARY Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose	3.5; 5.7; 5.5; 7.8	—
SECONDARY Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose	2.3; 6.0; 5.3; 8.3	—
SECONDARY Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose	7.3; 7.3; 5.7; 8.0	—
SECONDARY Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose	20.0; 29.4; 10.4; 8.2	—
SECONDARY Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose	0.0; 0.0; 0.0; 0.0	—
SECONDARY Duration When PI-NRS Scores Were >5 - From Post EP3 to 10 Hours Post-dose	0.0; 0.0; 0.0; 0.0	—
SECONDARY Duration When PI-NRS Scores Were >5 - From Post EP4 to 28 Hours Post-dose	0.0; 0.0; 0.0; 0.0	—
SECONDARY Number of Participants With Participant's Global Satisfaction Score	1; 3; 0; 4; 2; 1	—
SECONDARY Time to First Use of Rescue Therapy or Medication	14.9; 2.3; 15.3; 10.3	1.0000
SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771	652100; 657500	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771	652400; 658000	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-05089771	66760; 59080	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771	3.95; 6.00	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	5; 5; 5; 4; 0; 0	—
SECONDARY Number of Participants With Laboratory Abnormalities	2; 2; 2; 2	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature	0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure	0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG)	0; 0; 0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Male and or female subjects between the ages of 18-78 years
Subject has clinical signs of IEM
Minimum BMI 17.5kg/m2 and total body weight >50kg

Exclusion Criteria

Other severe pain conditions, e.g. rheumatologic, that may impair subject's self-assessment of pain due to IEM.
Evidence of clinically significant hypertension, clinically significant hematological, dermatological, renal, endocrine (except diabetes mellitus), pulmonary, gastrointestinal, cardiovascular, hepatic, neurological (other than IEM), or allergic disease (including drug allergies but excluding untreated asymptomatic seasonal allergies).
Subjects with severe obesity.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01769274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.