Multicenter clinical trial to evaluate efficacy and safety of diclofenac 1% gel produced by Epifarma s.r.l. compared to Voltaren¿ Emulgel¿ 1% gel

Phase 1

• Conditions: Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments; MedDRA version: 23.1Level: SOCClassification code 10022117Term: Injury, poisoning and procedural complicationsSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: PTClassification code 10050584Term: ContusionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-001779-29-IT
• Lead Sponsor: EPIFARMA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 749

Inclusion Criteria

1. Male and female patients aged 18-65 years;
2. Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments);
3. Patient with pain at rest in only one body surface area affected by injury/contusion;
4. Presence of mild to moderate pain at rest, defined as a scored VAS = 20 mm and = 60 mm, in the injured area;
5. Female and of child-bearing potential, (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first administration;
6. Satisfactory general health status as determined by the investigator based on medical history and physical examination;
7. Patients must understand and provide written informed consent before they can participate in the study. He/she must understand the study procedures of the trial, and be willing to complete the required assessments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion Criteria

1. Patient unwilling to give an informed consent approval;
2. Patient with presence of pain at rest in more than one body surface area affected by the injury/contusion;
3. Patient with a chronic painful or flogistic disease (from more than three months);
4. Patient with painful or flogistic (inflammatory) disease arising from fractures or severe trauma events;
5. Pregnancy or lactation period throughout the whole study duration;
6. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence;
7. Presence of concurrent skin disorders or open wounds in the area to be treated;
8. History of alcohol or drug abuse;
9. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation;
10. Known hypersensitivity to non-steroid anti-inflammatory drugs, and in particular to paracetamol;
11. Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of paracetamol) in the week before the study. Chronic intake of small doses of acetylsalicylic acid (= 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study;
12. Any other treatment or medication for the same or other indications that, according to its pharmacological properties and in the opinion of the investigator, can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) in the week before the study;
13. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that can't be interrupted and interferes with the conduct of the trial;
14. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening;
15. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results;
16. Participation in any other clinical study within 30 days prior to the screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified