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Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

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NCT01455428

Last updated on May 9, 2018
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Study Location
Peking University First Hospital
Beijing, Beijing, 100034 China
See other locations
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

NCT01455428
Pfizer
Completed
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)

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Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
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 )
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Postherpetic Neuralgia ( PHN )
  • Drug: Lyrica (pregabalin)
    Capsule, 300 mg/d, BID, 8 weeks treatment
  • Drug: Placebo
    Capsule, 300 mg/d, BID, 8 weeks treatment
  • Experimental: Lyrica (pregabalin)
    Intervention: Drug: Lyrica (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
223
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01455428
A0081276
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2015

ICMJE     Data element required by the

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

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