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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00159640




Registration number
NCT00159640
Ethics application status
Date submitted
7/09/2005
Date registered
12/09/2005
Date last updated
28/03/2007

Titles & IDs
Public title
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Scientific title
A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
Secondary ID [1] 0 0
A4451006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PD-217,014

Treatment: Drugs: PD-217,014


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
- 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)
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Warrawong
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Kippa Ring
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
- Warrawong
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Kippa Ring
Recruitment postcode(s) [4] 0 0
- Maroochydore
Recruitment postcode(s) [5] 0 0
- Bedford Park
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Brno
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Ceske Budejovice
Country [7] 0 0
Czech Republic
State/province [7] 0 0
CZ-Praha 8
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Plzen
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha 5
Country [10] 0 0
Netherlands
State/province [10] 0 0
Arnhem
Country [11] 0 0
Netherlands
State/province [11] 0 0
Breda
Country [12] 0 0
Netherlands
State/province [12] 0 0
Kampen
Country [13] 0 0
Netherlands
State/province [13] 0 0
Roosendaal
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
Stadskanaal
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Granada
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Malaga
Country [20] 0 0
Spain
State/province [20] 0 0
Sevilla
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Hants
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Northants
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
State/province [24] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00159640
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00159640