Pain Clinical Trial
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
| NCT number | NCT00159640 |
| Other study ID # | A4451006 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | September 7, 2005 |
| Last updated | March 27, 2007 |
| Start date | February 2004 |
| Verified date | March 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Department of Health |
| Study type | Interventional |
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
| Status | Terminated |
| Enrollment | 315 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Bedford Park | South Australia |
| Australia | Pfizer Investigational Site | Kippa Ring | Queensland |
| Australia | Pfizer Investigational Site | Maroochydore | Queensland |
| Australia | Pfizer Investigational Site | Perth | Western Australia |
| Australia | Pfizer Investigational Site | Warrawong | New South Wales |
| Australia | Pfizer Investigational Site | Westmead | New South Wales |
| Australia | Pfizer Investigational Site | Woodville | |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | Kelowna | British Columbia |
| Canada | Pfizer Investigational Site | Sherbrooke | Quebec |
| Canada | Pfizer Investigational Site | Ste-foy | Quebec |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Unknown | |
| Czech Republic | Pfizer Investigational Site | Brno | |
| Czech Republic | Pfizer Investigational Site | Ceske Budejovice | |
| Czech Republic | Pfizer Investigational Site | CZ-Praha 8 | |
| Czech Republic | Pfizer Investigational Site | Plzen | |
| Czech Republic | Pfizer Investigational Site | Praha 5 | |
| Netherlands | Pfizer Investigational Site | Arnhem | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Kampen | |
| Netherlands | Pfizer Investigational Site | Roosendaal | |
| Netherlands | Pfizer Investigational Site | Rotterdam | |
| Netherlands | Pfizer Investigational Site | Stadskanaal | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Granada | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Malaga | |
| Spain | Pfizer Investigational Site | Sevilla | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Northampton | Northants |
| United Kingdom | Pfizer Investigational Site | Portsmouth | Hants |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Australia, Canada, Czech Republic, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | - 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) |
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