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

NCT04976088 | Completed Phase 3

• 1 other identifier: EQI7_16_02
• Study Type: interventional
• Target: 214
• Locations: 3 countries
• Sites: 16

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.

Conditions

Trauma Injury; Inflammation

Keywords

traumatic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in VAS score (Visual Analogue Scale from 0 to 100 mm, where the left extreme means "No pain = 0" while the right extreme means "Worst Pain Imaginable = 100") for pain at rest at 72 ± 2 hours (Day 4) after treatment start.

  Non-inferior efficacy of Test (once a day) over Reference (once a day) in reduction of pain after 3 days post-Baseline (72± 2 hours, Day 4), and superior efficacy of Test and Reference to Placebo (once a day) in improving pain at rest at 72 ± 2 hours (Day 4) after Baseline in patients with painful and phlogistic disease due to acute traumatic events of the limbs. A 100-mm Visual Analogue Scale (VAS) will be used for the assessment of pain at rest, from 0 to 100, where "No pain = 0" while "Worst Pain Imaginable = 100".

  72 hours

Secondary Outcomes (19)

• Area under the curve (AUC) for pain at rest at Day 4 and Day 8 (SPID0-4d and SPID0-8d)

  Day 4 and Day 8

• Change from baseline of VAS (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100") for pain at rest at the other study time-points (including patients' home measurements), from Day 1 to Day 8.

  Day 1, Day 2, Day 3, Day 4, Day 5,Day 6, Day 7, Day 8

• Time to resolution of pain at rest, measured through VAS Scale (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100") during from Baseline to Day 8.

  From Day 1 until the date of resolution of pain at rest (maximum Day 8)

• Change from baseline in VAS score (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100") for pain on movement at 72 ± 2 hours (Day 4) and at 168 ± 2 hours (Day 8) after treatment start

  Day 4 and Day 8

• Proportion of responder patients (defined as a decrease ≥ 50% of baseline VAS (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100") for pain at rest and on movement) at 72 ± 2 hours (Day 4) after treatment start

  Day 4

Study Arms (3)

Group A Test

EXPERIMENTAL

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

Drug: Diclofenac Sodium 140 mg medicated plaster

Group B Reference

ACTIVE COMPARATOR

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®

Drug: Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector

Group C Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Diclofenac Sodium 140 mg medicated plaster DRUG

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

Also known as: EQI7

Group A Test

Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector DRUG

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

Also known as: Flector

Group B Reference

Placebo DRUG

Placebo: Placebo plaster, topical application once a day.

Also known as: Placebo plaster

Group C Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age range 18-65 years (included);
• Patient with painful and phlogistic (inflammatory response) disease due to acute traumatic events (injury/contusion) of the limbs;
• Patient with pain at rest in only one limb surface area affected by injury/contusion;
• Written informed consent to participate in the study obtained according to GCP;
• 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;
• Good general health as determined by the Investigator based on medical history and physical examination;
• 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;
• 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

You may not qualify if:

• Patient with a chronic painful or phlogistic disease (from more than three months);
• Patient with painful or phlogistic disease arising from fractures or severe trauma events;
• Pregnancy or lactation period throughout the whole study duration;
• 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\*;
• Presence of concurrent skin disorders or open wounds in the area to be treated;
• History of alcohol or drug abuse;
• History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation;
• Known hypersensitivity to non-steroidal anti-inflammatory drugs and to paracetamol;
• 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;
• 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;
• 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;
• History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days before Visit 1;
• 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;
• Known malignant diseases in the last 5 years;
• 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);

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (16)

Praxis Dr. med. Helmut Pabst

Gilching, 82205, Germany

Location

Praxis Dr. Jürgen Ulrich Schaale-Maas

Rheinbach, 53359, Germany

Location

Synexus Budapest DRC

Budapest, 1036, Hungary

Location

Magyar Honvédség, Egészségügyi Központ Baleseti Sebészeti Osztály

Budapest, 1134, Hungary

Location

Uzsoki utcai Kórház Ortopéd-traumatológiai Osztály

Budapest, 1146, Hungary

Location

Synexus Debrecen AS

Debrecen, 4025, Hungary

Location

Platán Egészségcentrum

Eger, 3300, Hungary

Location

Synexus Magyarország kft. Gyula DRS

Gyula, 5700, Hungary

Location

Shawfar-med Kft

Kalocsa, 6300, Hungary

Location

Jutrix Kft.

Kecskemét, 6000, Hungary

Location

Bács-Kiskun Megyei Kórház Kiskunfélegyházi Városi Kórház és Rendelőintézet

Kiskunfélegyháza, 6101, Hungary

Location

G&V Pharma-Med Bt.

Makó, 6901, Hungary

Location

Nagyatádi Kórház Reumatológiai Osztály

Nagyatád, 7500, Hungary

Location

Synexus Magyarország EÜ szolg Kft.

Zalaegerszeg, 8900, Hungary

Location

Ambulatorio MMG dott. Paolo Picco

Sant'Olcese Chiesa, Genova, 16010, Italy

Location

Ambulatorio MMG dott. Andrea Pedemonte

Genova, 16162, Italy

Location

MeSH Terms

Conditions

Accidental Injuries; Inflammation

Interventions

Diclofenac; diclofenac hydroxyethylpyrrolidine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nicola Giordan

  Fidia Farmaceutici s.p.a.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: July 26, 2021
• Study Start: May 25, 2018
• Primary Completion: October 27, 2018
• Study Completion: October 27, 2018
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); HU (12); IT (2)