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Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy

NCT03749642 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-05-27

No results posted yet for this study

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.

Conditions

  • Painful Diabetic Neuropathy

Interventions

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.

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Principal Investigators

  • Solomon Tesfaye, MD · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Czechia
  • France
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749642 on ClinicalTrials.gov