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First received: October 13, 2022

Clinical Trial: A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Diabetic Peripheral Neuropathic Pain

Study Type: INTERVENTIONAL


Official Title: A Phase 2 Study to Evaluate the Safety and Efficacy of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Brief Summary: This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and PK of RTA 901 in qualified subjects with DPNP.Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and a Placebo.The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1.A total of 384 subjects will be randomized in this study.Each part will have 192 subjects, with 64 subjects randomized 1:1:1 to…

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