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Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs

NCT04976088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-10-02

No results posted yet for this study

Summary

Phase III, multinational, multicentre, randomized, prospective, double blind, parallel groups, placebo-controlled study to evaluate the analgesic effects of Test Diclofenac Sodium 140mg medicated plaster, Reference DIEP 180 mg medicated plaster, Flector® and Placebo plaster in patients with painful and phlogistic disease due to acute traumatic events of the limbs.

Conditions

Interventions

DRUG

Diclofenac Sodium 140 mg medicated plaster

Test product: Diclofenac Sodium 140 mg medicated plaster, topical application once a day

DRUG

Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector

Reference product: Active-comparator, Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector®, topical application once a day

DRUG

Placebo

Placebo: Placebo plaster, topical application once a day.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Nicola Giordan · Fidia Farmaceutici s.p.a.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2018-10-27
Completion
2018-10-27

Countries

  • Germany
  • Hungary
  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT04976088 on ClinicalTrials.gov