The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablet versus placebo for postherpetic neuralgia.
This is a randomized, double-blind, multicenter, placebo-controlled trial to compare the efficacy and safety of pregabalin SR vs placebo in patients with PHN. The study is conducting at 27 study centers in China. Patients were randomized to receive pregabalin, starting at 165 mg/day and increasing to a maintenance dose of 330 or 660 mg/day, or placebo. The study includes a 1-week, single-blind, placebo run-in period; a 2-week dose-escalation/optimization phase; a 12-week, fixed-dose treatment period; and a 1-week taper phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
same intervention as the experimental group
According to the efficacy and safety in titration
According to the efficacy and safety in titration
Number of Responders
A responder is defined as a subject with a 30% reduction in weekly mean pain score from baseline to endpoint
Time frame: 15 weeks
50% reduction in weekly mean pain score from baseline to study completion
Time frame: 15 weeks
Change of Mean Pain Scores from study completion to baseline
Time frame: 15 weeks
Change of Mean Sleep Interference Scores from study completion to baseline
Time frame: 15 weeks
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According to the efficacy and safety in titration.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijing Chao-yang Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Friendship Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-Sen Memory Hospital , Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGThe Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
RECRUITINGFourth Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITING...and 17 more locations