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Trauma InjuryPhase 3NCT04976088

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

A Phase 3 study testing Diclofenac Sodium 140 mg medicated plaster and Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector in people with Trauma Injury and Inflammation, run by Fidia Farmaceutici s.p.a. at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Trauma Injury, Inflammation
What is being tested?
Diclofenac Sodium 140 mg medicated plaster and Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
16 sitesin 3 countries
Study dates
25 May 2018to 27 Oct 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 20Show fewer
  • 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);
  • Anticipated poor compliance by the patient;
  • Previous participation in this clinical trial;
  • Any relevant surgical treatment during the previous 2 months or planned during the trial;
  • Patient with a history of serious psychiatric disorders;
  • 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

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

Hungary12 sites

  • Synexus Budapest DRC

    Budapest, 1036

  • Magyar Honvédség, Egészségügyi Központ Baleseti Sebészeti Osztály

    Budapest, 1134

  • Uzsoki utcai Kórház Ortopéd-traumatológiai Osztály

    Budapest, 1146

  • Synexus Debrecen AS

    Debrecen, 4025

  • Platán Egészségcentrum

    Eger, 3300

  • Synexus Magyarország kft. Gyula DRS

    Gyula, 5700

  • Shawfar-med Kft

    Kalocsa, 6300

  • Jutrix Kft.

    Kecskemét, 6000

  • Bács-Kiskun Megyei Kórház Kiskunfélegyházi Városi Kórház és Rendelőintézet

    Kiskunfélegyháza, 6101

  • G&V Pharma-Med Bt.

    Makó, 6901

  • Nagyatádi Kórház Reumatológiai Osztály

    Nagyatád, 7500

  • Synexus Magyarország EÜ szolg Kft.

    Zalaegerszeg, 8900

Other trials in Hungary

Germany2 sites

  • Praxis Dr. med. Helmut Pabst

    Gilching, 82205

  • Praxis Dr. Jürgen Ulrich Schaale-Maas

    Rheinbach, 53359

Other trials in Germany

Italy2 sites

  • Ambulatorio MMG dott. Andrea Pedemonte

    Genova, 16162

  • Ambulatorio MMG dott. Paolo Picco

    Sant'Olcese Chiesa, Genova, 16010

Other trials in Italy

About this study

Official title: Randomized, Double Blind, Parallel-groups, Non-inferiority Versus Flector® and Superiority Versus Placebo, Phase III Clinical Trial With Diclofenac Sodium 140 mg Medicated Plaster in Patients With Impact Injuries of the Limbs

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.

Read the 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.

Being tested
Diclofenac Sodium 140 mg medicated plaster, Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector, Placebo
Keywords
traumatic
Medical subject headings
Accidental Injuries, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac Sodium 140 mg medicated plasterDrug

    Also called EQI7

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

  • Diclofenac epolamine (DIEP) 180mg medicated plaster, FlectorDrug

    Also called Flector

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

  • PlaceboDrug

    Also called Placebo plaster

    Placebo: Placebo plaster, topical application once a day.

Study groups in NCT04976088
Study groupRoleWhat they receive
Group A TestExperimentalTest product: treated once a day (morning) with the medicated plaster containing 140 mg Diclofenac Sodium for seven days Diclofenac Sodium 140 mg medicated plaster
Receives: Drug: Diclofenac Sodium 140 mg medicated plaster
Group B ReferenceActive comparatorReference 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®
Receives: Drug: Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector
Group C PlaceboPlacebo comparatorPlacebo: treated once a day (morning) with the placebo plaster for seven days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 72 hours

Secondary outcomes (19)

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

    To compare Test to Reference and Placebo with regard to pain relief (pain at rest and pain on movement) at Day 4 and Day8, assessed through the AUC (Area Under the Curve) of VAS measurements (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") at Day 4 and Day 8.

    Measured: Day 4 and Day 8

  2. 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.

    To compare efficacy of the Test product to Reference and Placebo with regard to pain relief (pain at rest and pain on movement) from Day 1 to Day 8.

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

  3. 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.

    To compare efficacy of Test in comparison to Reference and Placebo with regard to time to resolution of pain (pain at rest and pain on movement), measured with VAS score (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100").

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

  4. 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

    To compare efficacy of Test to Reference and Placebo with regard to pain relief (pain on movement), measured with VAS score (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100") at Day 4 and Day 8.

    Measured: Day 4 and Day 8

  5. 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

    To compare efficacy of Test to Reference and Placebo with regard to proportion of responders to pain relief (pain at rest and pain on movement) at Day 4, considering a decrease as ≥ 50% of baseline VAS (Visual Analogue Scale 0-100 mm, where "No pain = 0" and "Worst Pain Imaginable = 100")

    Measured: Day 4

  6. Proportion of patients that used rescue medication (paracetamol) from Baseline to Day 8 usign a patient diary

    To compare the proportion of patients that used rescue medication from Baseline to Day 8 among the three treatment arms (Test, Refrence and Placebo) using a patient diary

    Measured: From Baseline to Day 8

  7. Amount of tablets of rescue medication consumed from Baseline to Day 8, using a patient diary

    To compare the amount of consumption of tablets of paracetamol among the three treatment arms (Test, Refrence and Placebo) using a patient diary

    Measured: From Baseline to Day 8

  8. IMP adhesion, performed daily by patients and at Day 4 and Day 8 by the open staff member; following 5-point ordinal scale: 0:≥90% adhered; 1:≥75% to <90% adhered; 2:≥50% to <75% adhered; 3:<50% adhered but not detached; 4:Plaster detached

    To compare the adhesion of Test to Reference and Placebo in the site of application from Baseline to Day 8, 5-point ordinal scale: 0:≥90% adhered; 1:≥75% to <90% adhered; 2:≥50% to <75% adhered; 3:<50% adhered but not detached; 4:Plaster detached

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

  9. Safety as change from baseline to Day 8 evaluated by physical examination using observation, palpitation, percussion, and auscultation

    To compare Test with Reference and Placebo in patient safety as change from baseline to Day 8 using observation, palpitation, percussion, and auscultation

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  10. Safety as change from baseline to Day 8 evaluated by systolic blood pressure measured in mmHg

    To compare Test with Reference and Placebo in systolic blood pressure, measured in mmHg, as change from baseline to Day 8

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  11. Safety as change from baseline to Day 8 evaluated by diastolic blood pressure measured in mmHg

    To compare Test with Reference and Placebo in diastolic blood pressure, measured in mmHg, as change from baseline to Day 8

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  12. Safety as change from baseline to Day 8 evaluated by heart rate measured in bpm

    To compare Test with Reference and Placebo in heart rate, measured in bpm, as change from baseline to Day 8

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  13. Safety as change from baseline to Day 8 evaluated by tracking the number of patient withdrawals

    To compare Test with Reference and Placebo in patient safety as change from baseline to Day 8, tracking the number of withdrawals

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  14. Safety as change from baseline to Day 8 evaluated by tracking the number of adverse events

    To compare Test with Reference and Placebo in patient safety as change from baseline to Day 8, tracking the number of adverse events

    Measured: Day 1, Day 2, Day3, Day 4, Day 5,Day 6, Day 7, Day 8

  15. Local tolerability (erythema) at the IMP application site by Investigator at Day 1, Day 4 and Day 8 based on a 8-point categorical scale, where 0=no evidence of irritation and 7=strong reaction spreading beyond test site

    To compare Test with Reference and Placebo in relation to the level of irritation on the application site

    Measured: Day 1, Day 4 and Day 8

  16. Local tolerability (itching) at the IMP application site by Investigator at Day 1, Day 4 and Day 8 based on a 4-point categorical scale, where 0=absent and 3=severe

    To compare Test with Reference and Placebo in relation to the level of itching on the application site

    Measured: Day 1, Day 4 and Day 8

  17. Local tolerability (burning) at the IMP application site by Investigator at Day 1, Day 4 and Day 8 based on a 4-point categorical scale, where 0=absent and 3=severe

    To compare Test with Reference and Placebo in relation to the level of burning on the application site

    Measured: Day 1, Day 4 and Day 8

  18. Local tolerability (local pain) at the IMP application site by Investigator at Day 1, Day 4 and Day 8 based on a 4-point categorical scale, where 0=absent and 3=severe

    To compare Test with Reference and Placebo in relation to the level of local pain on the application site

    Measured: Day 1, Day 4 and Day 8

  19. Global assessment of local tolerability at IMP administration site by Investigator and patient according to the following score: 3=excellent; 2=good; 1=fair; 0=poor, assessed at Day 4 and Day 8.

    To compare Test with Reference and Placebo in relation to the global assessment of local tolerability on the application site

    Measured: Day 4 and Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2021
  2. Study start25 May 2018
  3. Primary completion27 Oct 2018
  4. Study completion27 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04976088
Sponsor's protocol ID
EQI7_16_02
Status last verified
Sep 2023
First submitted
2 Mar 2020
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac Sodium 140 mg medicated plaster and Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector in people with Trauma Injury and Inflammation, run by Fidia Farmaceutici s.p.a. at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Hungary, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04976088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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