Trazodone in Painful Diabetic Neuropathy

NCT03202979 ↗

Phase 2 Completed 142 enrolled Angelini Pharma Chiltern International Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.

Timeline

Start: 2017-05-16
Primary completion: 2018-08-09
Completion: 2018-08-09

Outcome

Missed primary endpoint

paper No statistically significant differences between groups were seen. PMID 32936427 ↗

paper a better trend was observed for TRZ30 vs placebo (95% confidence interval - 1.30, 0.15; p = 0.1179) PMID 32936427 ↗

Publications

Lipone P, Ehler E, Nastaj M, Palka-Kisielowska I, Cruccu G, Truini A, Di Loreto G, Del Vecchio A, Pochiero I, Comandini A, Calisti F, Cattaneo A. Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study. CNS Drugs. 2020 Nov;34(11):1177-1189. doi: 10.1007/s40263-020-00760-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trazodone	Small molecule	10 mg	Oral
Subject	Trazodone	Small molecule	20 mg	Oral