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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/02/2004
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/ct2/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/ct2/show/NCT00159640