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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01769274
First received: October 18, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Inherited Erythromelalgia
Drug: PF-05089771
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Average pain score postdose based on Pain Intensity Numerical Rating Scale (PI-NRS) scores [ Time Frame: 0-4 hr postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum pain score postdose based on Pain Intensity Numerical Rating Scale scores. [ Time Frame: 0-4 hr postdose ] [ Designated as safety issue: No ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5. [ Time Frame: 0-4hr postdose ] [ Designated as safety issue: No ]
  • Average pain score post Evoked Pain (EP) timepoint 2 based on Pain Intensity Numerical Rating Scale scores. [ Time Frame: 4-8 hr postdose ] [ Designated as safety issue: No ]
  • Maximum pain score post Evoked Pain timepoint 2 based on maximum Pain Intensity Numerical Rating Scale scores. [ Time Frame: 4-8h hr postdose ] [ Designated as safety issue: No ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 in the period post Evoked Pain timepoint 2 [ Time Frame: 4-8 hr postdose ] [ Designated as safety issue: No ]
  • Average pain score post Evoked Pain timepoint 3 based on Pain Intensity Numerical Rating scale scores [ Time Frame: 8-10 hr postdose ] [ Designated as safety issue: No ]
  • Maximum pain score post Evoked Pain timepoint 3 based on maximum Pain Intensity Numerical Rating Scale scores [ Time Frame: 8-10 hr postdose ] [ Designated as safety issue: No ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 post Evoked Pain timepoint 3 [ Time Frame: 8-10 hr postdose ] [ Designated as safety issue: No ]
  • Average pain score post Evoked Pain timepoint 4 based on Pain Intensity Numerical Rating scale scores [ Time Frame: 24-28 hr postdose ] [ Designated as safety issue: No ]
  • Maximum pain score post Evoked Pain timepoint 4 based on maximum Pain Intensity Numerical Rating Scale scores [ Time Frame: 24-28 hr postdose ] [ Designated as safety issue: No ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 post Evoked Pain timepoint 4 [ Time Frame: 24-28 hr postdose ] [ Designated as safety issue: No ]
  • Patient's global satisfaction with study medication based on categorical rating scale [ Time Frame: 4 hr postdose ] [ Designated as safety issue: No ]
  • Time to first rescue therapy or medication post dose [ Time Frame: 0-28 hr postdose ] [ Designated as safety issue: No ]
  • Plasma concentrations of PF-05089771, maximum observed concentration (Cmax), time to maximum concentration (Tmax) [ Time Frame: Day 1 predose, then 0.5hr, 2hr, 4hr, 6hr and 24hr postdose ] [ Designated as safety issue: No ]
  • Type, incidence and severity of Laboratory test result abnormalities as a measure of safety and toleration [ Time Frame: Day 0, Day 2; 24 hr postdose ] [ Designated as safety issue: No ]
  • Type, incidence and severity of Adverse Events in study subjects [ Time Frame: up to 28 days post last dose ] [ Designated as safety issue: No ]
  • Blood pressure changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, Day -1, Predose and 6hr post dose ] [ Designated as safety issue: No ]
  • Electrocardiogram changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, predose, 6 hr 24 hr post dose ] [ Designated as safety issue: No ]
  • Pulse rate changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, Day -1, Predose and 6hr post dose ] [ Designated as safety issue: No ]
  • Reason for first rescue therapy or medication postdose [ Time Frame: 0-28 hr postdose ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05089771 1600 mg 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.
Placebo Comparator: Placebo comparator: matching placebo
Single oral dose of placebo for PF-05089771 1600 mg
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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769274

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01769274     History of Changes
Other Study ID Numbers: B3291006
Study First Received: October 18, 2012
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erythromelalgia
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 28, 2014