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Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Fundamental Research
Gulf Shores, Alabama, 36542 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post Herpetic 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

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

- At screening (V1) and enrollment (V2), patients must have a score of greater than or
equal to 4 on the Pain Numeric Rating Scale (1 week recall period).

- At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within
the last 7 days and the average pain score must be greater than or equal to 4.

- Male or female of any race, at least 18 years of age, and using appropriate methods of
contraception

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

- Creatinine clearance

- Skin conditions in the affected dermatome that could alter sensation

- Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days
should be washed out of pregabalin for at least 30 days prior to screening visit.
Patients who had not responded to pregabalin

NCT01270828
Pfizer
Completed
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

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Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Post Herpetic Neuralgia
  • Drug: Pregabalin
    Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
  • Drug: placebo
    Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
  • Experimental: Pregablain CR tablet 82.5 to 660mg
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    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
806
November 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
  • At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
  • At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
  • Male or female of any race, at least 18 years of age, and using appropriate methods of contraception

Exclusion Criteria:

  • Creatinine clearance <30 mL/min (estimated from serum creatinine).
  • Skin conditions in the affected dermatome that could alter sensation
  • Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Colombia,   Croatia,   Czech Republic,   Denmark,   Germany,   Hong Kong,   India,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Sweden,   Taiwan,   Ukraine,   United States
Puerto Rico,   Singapore
 
NCT01270828
A0081224
2009-016766-86 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

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

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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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