Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
This study has been terminated.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159640
First received: September 7, 2005
Last updated: March 27, 2007
Last verified: March 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: PD-217,014 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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)
| Estimated Enrollment: | 315 |
| Study Start Date: | February 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159640
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| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Warrawong, New South Wales, Australia | |
| Pfizer Investigational Site | |
| Westmead, New South Wales, Australia | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Kippa Ring, Queensland, Australia | |
| Pfizer Investigational Site | |
| Maroochydore, Queensland, Australia | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Bedford Park, South Australia, Australia | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Perth, Western Australia, Australia | |
| Australia | |
| Pfizer Investigational Site | |
| Woodville, Australia | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada | |
| Pfizer Investigational Site | |
| Ste-foy, Quebec, Canada | |
| Canada | |
| Pfizer Investigational Site | |
| Unknown, Canada | |
| 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, Czech Republic | |
| 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, Netherlands | |
| 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, Spain | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Portsmouth, Hants, United Kingdom | |
| Pfizer Investigational Site | |
| Northampton, Northants, United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00159640 History of Changes |
| Other Study ID Numbers: | A4451006 |
| Study First Received: | September 7, 2005 |
| Last Updated: | March 27, 2007 |
| Health Authority: | United Kingdom: Department of Health |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013