Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

Phase 2 Completed 240 enrolled Angelini Pharma Chiltern International Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period.

Timeline

Start: 2018-11-22
Primary completion: 2020-06-06
Completion: 2020-06-06

Publications

Tesfaye S, Saravanan P, Ehler E, Zinek K, Palka-Kisielowska I, Nastaj M, Serusclat P, Lipone P, Vergallo A, Quarchioni E, Calisti F, Comandini A, Cattaneo A. Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study. Pain Ther. 2024 Aug;13(4):987-1006. doi: 10.1007/s40122-024-00624-3. Epub 2024 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Small molecule	25 mg	Oral
Subject	Gabapentin	Small molecule	50 mg	Oral
Subject	Gabapentin	Small molecule	100 mg	Oral
Subject	Gabapentin	Small molecule	600 mg	Oral
Subject	Trazodone	Small molecule	2.5 mg	Oral
Subject	Trazodone	Small molecule	5 mg	Oral
Subject	Trazodone	Small molecule	10 mg	Oral

Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

Summary

Timeline

Publications

Drugs

Indications