Clinical trial NCT00159640: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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:
measure: - 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)
Other outcomes:
Locations:
city: Warrawong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Maroochydore
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Woodville
country: Australia
facility: Pfizer Investigational Site
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: CZ-Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Plzen
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Arnhem
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Kampen
country: Netherlands
facility: Pfizer Investigational Site
city: Roosendaal
country: Netherlands
facility: Pfizer Investigational Site
city: Rotterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Stadskanaal
country: Netherlands
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Portsmouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Hants
city: Northampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Northants
city: London
country: United Kingdom
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: