A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
NCT ID: NCT00394901
Last Updated: 2021-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
372 participants
INTERVENTIONAL
2006-09-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
Pregabalin 150mg/day
Pregabalin
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pregabalin 300mg/day
Pregabalin
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pregabalin 600mg/day
Pregabalin
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Interventions
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Placebo
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
Pregabalin
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pregabalin
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pregabalin
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Eligibility Criteria
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Inclusion Criteria
* Pain is sustained for more than 3 months after healing of herpes zoster skin rash.
Exclusion Criteria
* Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
* Creatinine clearance \</= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
* Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
* Skin conditions in the affected dermatome that could alter sensation.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Ichikawa, Chiba, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Pfizer Investigational Site
Kasuya-gun, Fukuoka, Japan
Pfizer Investigational Site
Maebaru-chūō, Fukuoka, Japan
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Akashi, Hyōgo, Japan
Pfizer Investigational Site
Amagasaki, Hyōgo, Japan
Pfizer Investigational Site
Himeji, Hyōgo, Japan
Pfizer Investigational Site
Kobe, Hyōgo, Japan
Pfizer Investigational Site
Nishinomiya, Hyōgo, Japan
Pfizer Investigational Site
Tsuchiura, Ibaraki, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Beppu, Ohita, Japan
Pfizer Investigational Site
Kishiwada, Osaka, Japan
Pfizer Investigational Site
Takatsuki, Osaka, Japan
Pfizer Investigational Site
Kawaguchi, Saitama, Japan
Pfizer Investigational Site
Kitamoto, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
Adachi-ku, Tokyo, Japan
Pfizer Investigational Site
Arakawa-ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Mitaka, Tokyo, Japan
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Suginami-ku, Tokyo, Japan
Pfizer Investigational Site
Toshima-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, , Japan
Pfizer Investigational Site
Fukushima, , Japan
Pfizer Investigational Site
Osaka, , Japan
Pfizer Investigational Site
Saitama, , Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081120
Identifier Type: -
Identifier Source: org_study_id
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