NCT03749642 is a Phase 2 clinical trial of trazodone/gabapentin 2.5/25 mg in Painful Diabetic Neuropathy, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A.

Who is sponsoring NCT03749642?

NCT03749642 is sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A.

What drugs are being tested in NCT03749642?

Interventions in NCT03749642: trazodone/gabapentin 2.5/25 mg, trazodone/gabapentin 5/50 mg, trazodone/gabapentin 10/100, Gabapentin, Placebo oral capsule.

What condition does NCT03749642 study?

NCT03749642 studies Painful Diabetic Neuropathy.

Is NCT03749642 still recruiting?

NCT03749642 is currently completed. Last updated 27 May 2021.

Last reviewed 2021-05-27 · How we verify

NCT03749642

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

Completed Phase 2 Last updated 27 May 2021

What this trial tests

Phase 2 trial testing trazodone/gabapentin 2.5/25 mg in Painful Diabetic Neuropathy in 240 participants. Completed in 6 June 2020.

Timeline

22 November 2018

Primary endpoint
6 June 2020

6 June 2020

Quick facts

Lead sponsor	Aziende Chimiche Riunite Angelini Francesco S.p.A
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	22 November 2018
Primary completion	6 June 2020
Estimated completion	6 June 2020
Sites	30 locations across France, United Kingdom, Poland, Czechia

Drugs / interventions tested

trazodone/gabapentin 2.5/25 mg — full drug profile →
trazodone/gabapentin 5/50 mg — full drug profile →
trazodone/gabapentin 10/100 — full drug profile →
Gabapentin (Gabapentin) — full drug profile →
Placebo oral capsule

Conditions studied

Painful Diabetic Neuropathy — all drugs for Painful Diabetic Neuropathy →

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A — full company profile →

Who can join

Adults 18 to 75, any sex, with Painful Diabetic Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacotherapeutic Options for Managing Neuropathic Pain: A Systematic Review and Meta-Analysis.
Di Stefano G, Di Lionardo A, Di Pietro G, Cruccu G, et al · · 2021 · cited 21× · PMID 33986899 · DOI 10.1155/2021/6656863
Efficacy and Safety of Trazodone and Gabapentin Fixed-Dose Combination in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose-Finding Study.
Tesfaye S, Saravanan P, Ehler E, Zinek K, et al · · 2024 · cited 3× · PMID 38914876 · DOI 10.1007/s40122-024-00624-3

Verify or expand the search:

Other recruiting trials for Painful Diabetic Neuropathy

Currently open trials in the same condition.

NCT06423391 — Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial · NA · active not recruiting
NCT05754190 — Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA · recruiting
NCT05777317 — Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy · NA · active not recruiting
NCT04699734 — Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy · NA · recruiting

Other Aziende Chimiche Riunite Angelini Francesco S.p.A trials

Trials by the same sponsor.

NCT07199543 — Palatability Study of Five Formulations of Benzydamine HCl Lozenges · Phase 1 · completed
NCT06922175 — REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization · recruiting
NCT06650631 — The Effectiveness of Heat Treatment on Knee Pain in Patients With Osteoarthritis - an International, Multicenter Clinica · NA · recruiting
NCT06773767 — Bioavailability of Trazodone Hydrochloride (New Polymer) vs. Trazodone Hydrochloride Contramid® at Steady-state. · Phase 1 · completed
NCT05867160 — Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03749642 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aziende Chimiche Riunite Angelini Francesco S.p.A
Last refreshed: 27 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03749642.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing