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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Inherited Erythromelalgia

Treatments: Drug: PF-05089771; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01769274

B3291006

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

PF-05089771 1600 mg

Experimental group

Treatment:

Drug: PF-05089771

Placebo comparator: matching placebo

Placebo Comparator group

Description:

Single oral dose of placebo for PF-05089771 1600 mg

Treatment:

Drug: Placebo