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

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NCT00614705

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Vina del Mar, V Region, 2520997 Chile
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postherpetic Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00614705
Pfizer
Completed
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

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PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuralgia, Postherpetic
  • Drug: PH-797804
    6 mg dose in oral capsule form, once daily for 28 days
  • Drug: Placebo
    oral capsule form, once daily for 28 days
  • Experimental: 1
    Intervention: Drug: PH-797804
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
 
 
NCT00614705
A6631013
Not Provided
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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