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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR419-Placebo sequence | Experimental | 30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks |
|
| Placebo-SR419 sequence | Experimental | placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR419 | Drug | SR419 capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Day 64 |
| Daily Sleep Interference Score |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of SR419 | To measure the plasma concentration of SR419 after dosing | on Day 15 and Day 36 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fa Bi Fan, MD | China-Japan Friendship Hospital | Principal Investigator |
| Yong Cui, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PARC Clinical Research, Royal Adelaide Hospital | Adelaide | Australia | ||||
| PARATUS Clinical Research Brisbane |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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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. |
| up to Day 64 |
| Adverse events | To collect the adverse events during the study | up to Day 70 |
| Brisbane |
| Australia |
| PARATUS Clinical Research Canberra | Canberra | Australia |
| 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 |
| Nanyang First People's Hospital | Nanyang | China |
| Huazhong University of Science and Technology Union Shenzhen Hospital | Shenzhen | China |
| The Second Hospital of Tianjin Medical University | Tianjin | China |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |