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

NCT ID: NCT04976088

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2018-10-27

Brief 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.

Detailed Description

This will be a 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 (once a day), Reference DIEP 180 mg medicated plaster, Flector® (once a day) and Placebo plaster once a day (i.e. the placebo arm) in patients with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs.

Conditions

Trauma Injury; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A Test

Test product: treated once a day (morning) with the medicated plaster containing 140 mg Diclofenac Sodium for seven days Diclofenac Sodium 140 mg medicated plaster

Group Type: EXPERIMENTAL

Diclofenac Sodium 140 mg medicated plaster

Intervention Type: DRUG

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

Group B Reference

Reference product: treated once a day (morning) with the medicated plaster containing DIEP 180 mg, Flector® for seven days Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector®

Group Type: ACTIVE_COMPARATOR

Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector

Intervention Type: DRUG

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

Group C Placebo

Placebo: treated once a day (morning) with the placebo plaster for seven days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo: Placebo plaster, topical application once a day.

Interventions

Diclofenac Sodium 140 mg medicated plaster

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

Intervention Type: 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

Intervention Type: DRUG

Placebo

Placebo: Placebo plaster, topical application once a day.

Intervention Type: DRUG

Other Intervention Names

EQI7; Flector; Placebo plaster

Eligibility Criteria

Inclusion Criteria

1. Male or female, age range 18-65 years (included);

2. Patient with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs;

3. Patient with pain at rest in only one limb surface area affected by injury/contusion;

4. Written informed consent to participate in the study obtained according to GCP;

5. Patients able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator's judgement;

6. Good general health as determined by the Investigator based on medical history and physical examination;

7. Female 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 IMP administration;

8. Presence of pain at rest in the injured area, defined by patient with a VAS ≥40 mm and ≤80 mm at Visit 1 on a 100 mm VAS

Exclusion Criteria

1. Patient with a chronic painful or phlogistic disease (from more than three months);

2. Patient with painful or phlogistic disease arising from fractures or severe trauma events;

3. Pregnancy or lactation period throughout the whole study duration;

4. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) 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*;

5. Presence of concurrent skin disorders or open wounds in the area to be treated;

6. History of alcohol or drug abuse;

7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation;

8. Known hypersensitivity to non-steroidal anti-inflammatory drugs and to paracetamol;

9. Use of non-steroid anti-inflammatory drugs and analgesics in the week before Visit 1 (with the exception of paracetamol, which should not be taken in the previous 8 hours), oral corticosteroids within 2 weeks or intravenous corticosteroids within 4 weeks before Visit 1. Chronic intake of small doses of acetylsalicylic acid (≤ 162 mg/day) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued (with no change on dosage) for the duration of the study;

10. 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 or other anticoagulant agents, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, etc.) in the week before Visit 1;

11. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that cannot be interrupted and interferes with the conduct of the trial;

12. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days before Visit 1;

13. History of uncontrolled chronic or acute concomitant disease (e.g. cardiac dysfunction, liver dysfunction, hemorrhagic diathesis, …) which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results;

14. Known malignant diseases in the last 5 years;

15. Pre-treatment of the traumatic event (injury/contusion) target of this study. Previous cooling (with ice, cooling spray) is authorized prior to Visit 1 (but not in the three hours preceding Visit 1);

16. Anticipated poor compliance by the patient;

17. Previous participation in this clinical trial;

18. Any relevant surgical treatment during the previous 2 months or planned during the trial;

19. Patient with a history of serious psychiatric disorders;

20. Participation in any other clinical study within 30 days prior to Visit 1. *Note: According to 4.1 paragraph "Birth control methods which may be considered as highly effective" of the CTFG/Recommendations related to contraception and pregnancy testing in clinical trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Giordan

Role: STUDY_DIRECTOR

Fidia Farmaceutici s.p.a.

Locations

Praxis Dr. med. Helmut Pabst

Gilching, , Germany

Praxis Dr. Jürgen Ulrich Schaale-Maas

Rheinbach, , Germany

Synexus Budapest DRC

Budapest, , Hungary

Magyar Honvédség, Egészségügyi Központ Baleseti Sebészeti Osztály

Budapest, , Hungary

Uzsoki utcai Kórház Ortopéd-traumatológiai Osztály

Budapest, , Hungary

Synexus Debrecen AS

Debrecen, , Hungary

Platán Egészségcentrum

Eger, , Hungary

Synexus Magyarország kft. Gyula DRS

Gyula, , Hungary

Shawfar-med Kft

Kalocsa, , Hungary

Jutrix Kft.

Kecskemét, , Hungary

Bács-Kiskun Megyei Kórház Kiskunfélegyházi Városi Kórház és Rendelőintézet

Kiskunfélegyháza, , Hungary

G&V Pharma-Med Bt.

Makó, , Hungary

Nagyatádi Kórház Reumatológiai Osztály

Nagyatád, , Hungary

Synexus Magyarország EÜ szolg Kft.

Zalaegerszeg, , Hungary

Ambulatorio MMG dott. Paolo Picco

Sant'Olcese Chiesa, Genova, Italy

Ambulatorio MMG dott. Andrea Pedemonte

Genova, , Italy

Countries

Germany; Hungary; Italy

Other Identifiers

EQI7_16_02

Identifier Type: -

Identifier Source: org_study_id