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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-22

Study Completion Date

2013-07-12

Brief Summary

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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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Detailed Description

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Conditions

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Inherited Erythromelalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-05089771 1600 mg

Group Type EXPERIMENTAL

PF-05089771

Intervention Type 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.

Placebo comparator: matching placebo

Single oral dose of placebo for PF-05089771 1600 mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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PF-05089771

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No