Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00159640
Collaborator
(none)
315
32
9.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Feb 1, 2004
Outcome Measures
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) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Warrawong | New South Wales | Australia | |
| 2 | Pfizer Investigational Site | Westmead | New South Wales | Australia | |
| 3 | Pfizer Investigational Site | Kippa Ring | Queensland | Australia | |
| 4 | Pfizer Investigational Site | Maroochydore | Queensland | Australia | |
| 5 | Pfizer Investigational Site | Bedford Park | South Australia | Australia | |
| 6 | Pfizer Investigational Site | Perth | Western Australia | Australia | |
| 7 | Pfizer Investigational Site | Woodville | Australia | ||
| 8 | Pfizer Investigational Site | Kelowna | British Columbia | Canada | |
| 9 | Pfizer Investigational Site | Halifax | Nova Scotia | Canada | |
| 10 | Pfizer Investigational Site | Toronto | Ontario | Canada | |
| 11 | Pfizer Investigational Site | Sherbrooke | Quebec | Canada | |
| 12 | Pfizer Investigational Site | Ste-foy | Quebec | Canada | |
| 13 | Pfizer Investigational Site | Brno | Czech Republic | ||
| 14 | Pfizer Investigational Site | Ceske Budejovice | Czech Republic | ||
| 15 | Pfizer Investigational Site | CZ-Praha 8 | Czech Republic | ||
| 16 | Pfizer Investigational Site | Plzen | Czech Republic | ||
| 17 | Pfizer Investigational Site | Praha 5 | Czech Republic | ||
| 18 | Pfizer Investigational Site | Arnhem | Netherlands | ||
| 19 | Pfizer Investigational Site | Breda | Netherlands | ||
| 20 | Pfizer Investigational Site | Kampen | Netherlands | ||
| 21 | Pfizer Investigational Site | Roosendaal | Netherlands | ||
| 22 | Pfizer Investigational Site | Rotterdam | Netherlands | ||
| 23 | Pfizer Investigational Site | Stadskanaal | Netherlands | ||
| 24 | Pfizer Investigational Site | Barcelona | Spain | ||
| 25 | Pfizer Investigational Site | Granada | Spain | ||
| 26 | Pfizer Investigational Site | Madrid | Spain | ||
| 27 | Pfizer Investigational Site | Malaga | Spain | ||
| 28 | Pfizer Investigational Site | Sevilla | Spain | ||
| 29 | Pfizer Investigational Site | Portsmouth | Hants | United Kingdom | |
| 30 | Pfizer Investigational Site | Northampton | Northants | United Kingdom | |
| 31 | Pfizer Investigational Site | London | United Kingdom | ||
| 32 | Pfizer Investigational Site |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00159640
Other Study ID Numbers:
- A4451006
First Posted:
Sep 12, 2005
Last Update Posted:
Mar 28, 2007
Last Verified:
Mar 1, 2007