NCT00159640

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for phase_2 pain

Geographic Reach
6 countries

31 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

March 28, 2007

Status Verified

March 1, 2007

First QC Date

September 7, 2005

Last Update Submit

March 27, 2007

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • - 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)

Interventions

PD-217,014DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Pfizer Investigational Site

Warrawong, New South Wales, Australia

Location

Pfizer Investigational Site

Westmead, New South Wales, Australia

Location

Pfizer Investigational Site

Kippa-Ring, Queensland, Australia

Location

Pfizer Investigational Site

Maroochydore, Queensland, Australia

Location

Pfizer Investigational Site

Bedford Park, South Australia, Australia

Location

Pfizer Investigational Site

Perth, Western Australia, Australia

Location

Pfizer Investigational Site

Woodville, Australia

Location

Pfizer Investigational Site

Kelowna, British Columbia, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Location

Pfizer Investigational Site

Ste-foy, Quebec, Canada

Location

Pfizer Investigational Site

Brno, Czechia

Location

Pfizer Investigational Site

CZ-Praha 8, Czechia

Location

Pfizer Investigational Site

České Budějovice, Czechia

Location

Pfizer Investigational Site

Pilsen, Czechia

Location

Pfizer Investigational Site

Prague, Czechia

Location

Pfizer Investigational Site

Arnhem, Netherlands

Location

Pfizer Investigational Site

Breda, Netherlands

Location

Pfizer Investigational Site

Kampen, Netherlands

Location

Pfizer Investigational Site

Roosendaal, Netherlands

Location

Pfizer Investigational Site

Rotterdam, Netherlands

Location

Pfizer Investigational Site

Stadskanaal, Netherlands

Location

Pfizer Investigational Site

Granada, Granada, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, Spain

Location

Pfizer Investigational Site

Málaga, MALAGA, Spain

Location

Pfizer Investigational Site

Seville, SEVILLA, Spain

Location

Pfizer Investigational Site

Barcelona, Spain

Location

Pfizer Investigational Site

Portsmouth, Hants, United Kingdom

Location

Pfizer Investigational Site

Northampton, Northants, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Pfizer Investigational Site

Location

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Last Updated

March 28, 2007

Record last verified: 2007-03

Locations

ES(5)GB(3)AU(7)CA(5)CZ(5)NL(6)