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

NCT01769274 | Completed Phase 2 Results

• 1 other identifier: B3291006
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Inherited Erythromelalgia

Outcome Measures

Primary Outcomes (1)

• Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose

  Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose.

  Every 15 minutes from 0 to 4 hours post-dose

Secondary Outcomes (22)

• Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose

  Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose

• Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose

  Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose

• Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose

  Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose

• Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose

  From 0 hour to 4 hours post-dose

• Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose

  From post EP2 to 8 hours post-dose

Study Arms (2)

PF-05089771 1600 mg

EXPERIMENTAL

Drug: PF-05089771

Placebo comparator: matching placebo

PLACEBO COMPARATOR

Single oral dose of placebo for PF-05089771 1600 mg

Drug: Placebo

Interventions

PF-05089771 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.

PF-05089771 1600 mg

Placebo 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.

Placebo comparator: matching placebo

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 27099175 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-05089771

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: January 16, 2013
• Study Start: October 22, 2012
• Primary Completion: July 12, 2013
• Study Completion: July 12, 2013
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)