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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 November 21, 2019

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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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Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
Official Title  ICMJE 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)
Brief SummaryThe 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)
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post Herpetic Neuralgia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Pregablain CR tablet 82.5 to 660mg
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications *Huffman CL, Goldenberg JN, Weintraub J, Sanin L, Driscoll J, Yang R, Chew ML, Scavone JM. Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial. Clin J Pain. 2017 Jul;33(7):569-578. doi: 10.1097/AJP.0000000000000445.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2015)
806
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2011)
290
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion DateSeptember 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Colombia,   Croatia,   Czech Republic,   Denmark,   Germany,   Hong Kong,   India,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Sweden,   Taiwan,   Ukraine,   United States
Removed Location CountriesPuerto Rico,   Singapore
 
Administrative Information
NCT Number  ICMJE NCT01270828
Other Study ID Numbers  ICMJE A0081224
2009-016766-86 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2015

ICMJE     Data element required by the

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

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