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PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

Primary Purpose

Neuralgia, Postherpetic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PH-797804
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, at least 18 years of age
  • Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
  • Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).

Exclusion Criteria:

  • Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
  • History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
  • Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
  • A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
  • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
  • ECG abnormalities at screening or randomization
  • Evidence of organ dysfunction or hematopoietic disorder

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale

Secondary Outcome Measures

PH-797804 pharmacokinetics
Patient global impression of change
Neuropathic Pain Symptom Inventory

Full Information

First Posted
January 31, 2008
Last Updated
May 9, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00614705
Brief Title
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
Official Title
A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PH-797804
Intervention Description
6 mg dose in oral capsule form, once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsule form, once daily for 28 days
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
PH-797804 pharmacokinetics
Time Frame
Weeks 1, 2, and 4
Title
Patient global impression of change
Time Frame
Week 4
Title
Neuropathic Pain Symptom Inventory
Time Frame
Baseline and Weeks 1, 2, and 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, at least 18 years of age Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN. Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS). Exclusion Criteria: Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks). Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG). A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0 ECG abnormalities at screening or randomization Evidence of organ dysfunction or hematopoietic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Vina del Mar
State/Province
V Region
ZIP/Postal Code
2520997
Country
Chile
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123098
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
114 54
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49616
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61052
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61178
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Bexhill on Sea
State/Province
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Weybridge
State/Province
Surrey
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631013&StudyName=PH-797804%20Versus%20Placebo%20For%20The%20Treatment%20Of%20Neuropathic%20Pain%20Associated%20With%20Post-Herpetic%20Neuralgia
Description
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PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

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