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

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NCT01769274

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]m
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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.

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Inherited ErythromelalgiaEvaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
NCT01769274
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Inherited Erythromelalgia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2013)		5
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2013)		20
Actual Study Completion Date  ICMJE July 12, 2013
Actual Primary Completion Date July 12, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01769274
Other Study ID Numbers  ICMJE B3291006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP