This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.
The study will evaluate the efficacy and safety of SR419 in PHN patients. Each subject will participate in the study for up to approximately 14 weeks. This includes a screening period, drug treatment period, and post-treatment safety follow-up period. This is a crossover design study, in which subjects will be administered with SR419 and placebo according to their randomized sequence, that is, eligible subjects will be randomized in a 1:1 ratio to 1 of 2 double-blind treatment sequences: 30 mg of SR419 administered TID followed by placebo administered TID or placebo administered TID followed by 30 mg of SR419 administered TID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
SR419 capsule
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, Australia
PARATUS Clinical Research Brisbane
Brisbane, Australia
PARATUS Clinical Research Canberra
Canberra, Australia
Daily Average Pain Score (DAPS)
To assess the difference between the two treatment periods in the weekly average of Daily Average Pain Score (DAPS) at the last week. The pain intensity numerical rating scale (PI-NRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: up to Day 64
Patient Global Impression of Change (PGIC)
To assess the proportion of subjects who rate their pain as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the end of each treatment period.
Time frame: up to Day 64
Daily Sleep Interference Score
To assess the within-subject difference between the two treatment periods in the weekly average of daily sleep interference scores at the last week. Pain-related sleep interference score was assessed on Daily Sleep Interference Scale (DSIS) which is an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: up to Day 64
Adverse events
To collect the adverse events during the study
Time frame: up to Day 70
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Genesis Research Services
Sydney, Australia
PARATUS Clinical Research Western Sydney
Sydney, Australia
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
...and 3 more locations