Phase 3Recruiting
YJ001 Spray for Diabetic Peripheral Neuropathic Pain
Multicenter, Randomized, Double-blind, Double Simulation, Positive Drug and Placebo Parallel Control Phase III Clinical Trial And Open-label Extension Trial of YJ001 for Spray Use the Treatment of Diabetic Peripheral Neuropathic Pain
- Sponsor
- Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. (Industry)
- Enrolment
- 400 planned
- Conditions
- Diabetic Peripheral Neuropathic Pain (DPNP)
- Interventions
- YJ001 spray simulant; YJ001 spray; Crisugabalin Besilate Capsules; Crisugabalin Besilate Capsules simulant
- Ages
- adults, older adults
- Registry
- NCT07859111
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to learn if YJ001 Spray works to treat diabetic patients with Diabetic Peripheral Neuropathic Pain..It will also learn about the safety of drug YJ001 Spray.This trial is divided into two parts. The first part of the trial is designed as a randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical trial with positive reference product and placebo; the second part is designed as a single-arm, open-label, multi-center clinical trial.In the first part, the trial was divided into the test group, the positive control group, and the placebo group. In the first part,The experimental group received YJ001 spray + clobazam besylate capsule placebo, the positive control group received YJ001 spray placebo + clobazam besylate capsule, and the placebo group received YJ001 spray placebo + clobazam besylate capsule placebo. In the second part, all participants were treated with the investigational product, and 30 trial participants underwent PK blood sample collection according to the protocol. Part I of the trial : To evaluate the…
Primary outcomes
- Change from baseline in Average Daily Pain Score (ADPS)
- Number of participants with clinically significant changes in safety parameters from baseline
History
Primary completion expected
Registered
Started