You are here

Our science / Clinical Trials / Find a Trial / NCT01603394

Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

Back to Search Print Save as PDF Bookmark Trial

NCT01603394

Last updated on May 10, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Leesburg, Florida, 34748 United States
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

- Subjects must have pain present for more than 3 months after the healing of the herpes
zoster skin rash.

- At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric
Rating Scale for Pain (1 week recall period).

- At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the
last 7 days and the average pain score must be >=4.

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

- Subjects having other severe pain that may confound assessment or self evaluation of
the pain due to PHN.

- Neurolytic or neurosurgical therapy for Postherpetic Neuralgia

- Skin conditions in the affected dermatome that could alter sensation.

NCT01603394
Pfizer
Terminated
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Neuralgia
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
NCT01256593
All Genders
Neuralgia
P4 (Pregabalin for Peripheral Posttraumatic Pain)
NCT00292188
All Genders
18+
Years
Multiple Sites
Diabetic Neuropathies, Neuralgia
Pregabalin Peripheral Neuropathic Pain Study
NCT00141219
All Genders
18+
Years
Multiple Sites
Post-Herpetic Neuralgia
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
NCT00159666
All Genders
18+
Years
Multiple Sites
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.
The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postherpetic Neuralgia
Drug: pregabalin
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
Experimental: Pregabalin (300-600 mg/day; 150 mg/day starting dose)
Intervention: Drug: pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
  • At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
  • At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.

Exclusion Criteria:

  • Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
  • Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
  • Skin conditions in the affected dermatome that could alter sensation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   South Africa,   United States
Ireland
 
NCT01603394
A9001464
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now