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

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NCT01603394

Last updated on May 10, 2018
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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

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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.

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