Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

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NCT01455428

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Study Location
Peking University First Hospital
Beijing, Beijing, 100034, China
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postherpetic Neuralgia ( PHN )
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

- Male or female Chinese subjects, ages ≥18 at screening

- Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash

- At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

- At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

- At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

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


- Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain
Visual Analog Scale (VAS) at randomization as compared to screening


- Subjects who have a high variability in pain scores during the 1 week screening
period, with any difference between two scores ﹥3

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Postherpetic Neuralgia ( PHN )Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
NCT01455428
  1. Beijing, Beijing
  2. Guangzhou, Guangdong
  3. Shenzhen, Guangdong
  4. Wuhan, Hubei
  5. Wuhan, Hubei
  6. Nanjing, Jiangsu
  7. Suzhou, Jiangsu
  8. Jinan, Shandong
  9. Hangzhou, Zhejiang
  10. Hangzhou, Zhejiang
  11. Beijing,
  12. Beijing,
  13. Beijing,
  14. Chengdu/wuhou D,
  15. Chongqing,
  16. Guangzhou,
  17. Guangzhou,
  18. Shang Hai,
  19. Shang Hai,
  20. Shanghai,
  21. Shanghai,
  22. Tianjin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
Official Title  ICMJE An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
Brief Summary To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia ( PHN )
Intervention  ICMJE
  • Drug: Lyrica (pregabalin)
    Capsule, 300 mg/d, BID, 8 weeks treatment
  • Drug: Placebo
    Capsule, 300 mg/d, BID, 8 weeks treatment
Study Arms  ICMJE
  • Experimental: Lyrica (pregabalin)
    Intervention: Drug: Lyrica (pregabalin)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: May 20, 2015)		223
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2011)		218
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female Chinese subjects, ages ?18 at screening
  • Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ?3 months after healing of the acute herpes zoster skin rash
  • At screening (V1), subjects must have a score ?40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
  • At randomization (V2), subjects must have a score ?40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
  • At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ?4 over the past 7 days

Exclusion Criteria:

  • Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
  • Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ?3
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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01455428
Other Study ID Numbers  ICMJE A0081276
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2015

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