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

NCT01270828

Last updated date
Study Location
Fundamental Research
Gulf Shores, Alabama, 36542, United States
Contact
1-800-718-1021

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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 <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

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Post Herpetic NeuralgiaSafety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
NCT01270828
  1. Gulf Shores, Alabama
  2. Chandler, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Phoenix, Arizona
  7. Tucson, Arizona
  8. Little Rock, Arkansas
  9. Little Rock, Arkansas
  10. Little Rock, Arkansas
  11. Carmichael, California
  12. Clovis, California
  13. Clovis, California
  14. Colton, California
  15. Laguna Hills, California
  16. Los Angeles, California
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  18. North Hollywood, California
  19. Redondo Beach, California
  20. Riverside, California
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  23. San Francisco, California
  24. Santa Monica, California
  25. West Covina, California
  26. Atlantis, Florida
  27. Boynton Beach, Florida
  28. Clearwater, Florida
  29. Clearwater, Florida
  30. Fort Myers, Florida
  31. Hialeah, Florida
  32. North Palm Beach, Florida
  33. Ocala, Florida
  34. Ocala, Florida
  35. Orlando, Florida
  36. Royal Palm Beach, Florida
  37. St. Petersburg, Florida
  38. Sunrise, Florida
  39. Tampa, Florida
  40. Tampa, Florida
  41. Boise, Idaho
  42. Bloomington, Illinois
  43. Chicago, Illinois
  44. Chicago, Illinois
  45. Evansville, Indiana
  46. Evansville, Indiana
  47. Evansville, Indiana
  48. Monroe, Louisiana
  49. Boston, Massachusetts
  50. Brockton, Massachusetts
  51. North Dartmouth, Massachusetts
  52. Ann Arbor, Michigan
  53. Bingham Farms, Michigan
  54. Kansas City, Missouri
  55. Saint Louis, Missouri
  56. Springfield, Missouri
  57. Missoula, Montana
  58. Lincoln, Nebraska
  59. Omaha, Nebraska
  60. Omaha, Nebraska
  61. Las Vegas, Nevada
  62. Albuquerque, New Mexico
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  64. Brooklyn, New York
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  68. Raleigh, North Carolina
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  70. Akron, Ohio
  71. Dayton, Ohio
  72. Kettering, Ohio
  73. Oklahoma City, Oklahoma
  74. Oklahoma City, Oklahoma
  75. Charleston, South Carolina
  76. Arlington, Texas
  77. Austin, Texas
  78. Dallas, Texas
  79. Richardson, Texas
  80. Waco, Texas
  81. Norfolk, Virginia
  82. Kenosha, Wisconsin
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  93. Osijek, Osjecko-baranjska županija
  94. Sisak, Sisacko-moslavacka županija
  95. Prerov I,
  96. Aalborg, Region Nordjylland
  97. Glostrup,
  98. Frankfurt/Main, Hessen
  99. Kiel-Kronshagen, Schleswig-Holstein
  100. Eichstaett,
  101. Hong Kong,
  102. Kowloon,
  103. Gurgaon, Haryana
  104. Bangalore, Karnataka
  105. Bangalore, Karnataka
  106. Mangalore, Karnataka
  107. New Delhi,
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  109. Lublin, Lubelskie
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  144. Simferopol,
  145. Vinnitsa,
  146. Zaporizhzhya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary 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)
Detailed Description Not 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 Date September 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 Countries Puerto Rico,   Singapore
 
Administrative Information
NCT Number  ICMJE NCT01270828
Other Study ID Numbers  ICMJE A0081224
2009-016766-86 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP