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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inherited Erythromelalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-78 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01769274
Pfizer
Completed
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia

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Similar Trials

Inherited Erythromelalgia
NCT01769274
All Genders
18+
Years
New Haven, Connecticut
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
A Randomized, Double Blind Third Party Open Placebo-Controlled Exploratory Study To Evaluate The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Inherited Erythromelalgia
  • Drug: 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.
  • 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.
  • Experimental: PF-05089771 1600 mg
    Intervention: Drug: PF-05089771
  • Placebo Comparator: Placebo comparator: matching placebo
    Single oral dose of placebo for PF-05089771 1600 mg
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01769274
B3291006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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