NCT03749642

Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

Efficacy and Safety of Fixed-Dose Combination (FDC) Products Containing Trazodone and Gabapentin in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose Finding Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The present phase II study is designed to collect preliminary data on the efficacy and safety of trazodone/gabapentin Fixed-Dose Combination (FDC)products for treatment of patients affected by painful diabetic neuropathy in a randomized controlled clinical trial. Diabetic peripheral neuropathic pain represents an important therapeutic challenge as its pathophysiology is not yet fully understood and pain relief is still unsatisfactory. The pharmacological treatments, with exception to those targeted to the glycemic control, are symptomatic and their use is limited by not universal efficacy, side effects or by the development of tolerance. A wide variety of drugs, used both alone and in combination, has shown to significantly reduce neuropathic pain when compared with placebo in randomized controlled trials, even though pain relief remains inadequate for most of the patients. In this contest, Angelini S.p.A is developing a fixed-dose combination medicinal product for the treatment of neuropathic pain containing low doses of active ingredients: trazodone, a widely used antidepressant drug, and gabapentin which is indicated for the treatment of neuropathic pain.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	trazodone/gabapentin 2.5/25 mg	The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.
DRUG	trazodone/gabapentin 5/50 mg	The total daily doses administered will be trazodone 15 mg and gabapentin 150 mg.
DRUG	trazodone/gabapentin 10/100	The total daily doses administered will be trazodone 30 mg and gabapentin 300 mg.
DRUG	Gabapentin	The total daily doses administered will be: * 600 mg from day 0 to day 6 (±1) * 900 mg from day 7 (±1) to day 13 (±1) * 1200 mg from day 14 (±1) to day 20 (±1) * 1800 mg from day 21 (±1) to day 56 (±2)
DRUG	Placebo oral capsule	Two capsules, three times a day, for 8 weeks.

Timeline

• Start date: 2018-11-22
• Primary completion: 2020-06-06
• Completion: 2020-06-06
• First posted: 2018-11-21
• Last updated: 2021-05-27

Locations

30 sites across 4 countries: Czechia, France, Poland, United Kingdom