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Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

Primary Purpose

Pain

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PD-217,014
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash. Patients at screening must have a score >=40 mm on the pain visual analogue scale. Exclusion Criteria: Patients with poor renal function. Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. Patients with abnormal electrocardiogram.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

Secondary Outcome Measures

- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)

Full Information

First Posted
September 7, 2005
Last Updated
March 27, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00159640
Brief Title
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Official Title
A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
315 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PD-217,014
Primary Outcome Measure Information:
Title
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.
Secondary Outcome Measure Information:
Title
- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash. Patients at screening must have a score >=40 mm on the pain visual analogue scale. Exclusion Criteria: Patients with poor renal function. Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. Patients with abnormal electrocardiogram.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Warrawong
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Pfizer Investigational Site
City
Kippa Ring
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
Pfizer Investigational Site
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Pfizer Investigational Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Pfizer Investigational Site
City
Woodville
Country
Australia
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-foy
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brno
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
CZ-Praha 8
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Plzen
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 5
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Arnhem
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Breda
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Kampen
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Roosendaal
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Stadskanaal
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
Country
Spain
Facility Name
Pfizer Investigational Site
City
Portsmouth
State/Province
Hants
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northampton
State/Province
Northants
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4451006&StudyName=Placebo+Controlled+Dose%2DResponse+Study+Of+PD%2D217%2C014+In+The+Treatment+Of+Postherpetic+Neuralgia
Description
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Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

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