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CompletedNCT04976088Updated Oct 2, 2023

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

A Phase 3 interventional study of Diclofenac Sodium 140 mg medicated plaster and Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector in Trauma Injury and Inflammation, sponsored by Fidia Farmaceutici s.p.a.. Completed at 16 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-02.

Sponsored by Fidia Farmaceutici s.p.a. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled May 2018, registered Mar 2020).
Phase
Phase 3
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

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.

02

Conditions studied

  • Trauma Injury
  • Inflammation

Keywords

  • traumatic
03

In context

Accidental Injuries

57 studies on the registry are indexed under Accidental Injuries; 30 are open to participants now.

This study's enrollment of 214 is above the median of 122 across 36 interventional studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Fidia Farmaceutici s.p.a. is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Browse Fidia Farmaceutici s.p.a. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
214 participants (actual)

Study arms

  • Experimental
    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

    Drug: Diclofenac Sodium 140 mg medicated plaster

  • Active comparator
    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®

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

  • Placebo comparator
    Group C Placebo

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

    Drug: Placebo

Interventions

06

What researchers measure

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".

    Time frame: 72 hours

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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").

    Time frame: 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.

    Time frame: 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")

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 4 and Day 8

07

Study locations

16 sites
  • Praxis Dr. med. Helmut Pabst
    Gilching, 82205, Germany
  • Praxis Dr. Jürgen Ulrich Schaale-Maas
    Rheinbach, 53359, Germany
  • Synexus Budapest DRC
    Budapest, 1036, Hungary
  • Magyar Honvédség, Egészségügyi Központ Baleseti Sebészeti Osztály
    Budapest, 1134, Hungary
  • Uzsoki utcai Kórház Ortopéd-traumatológiai Osztály
    Budapest, 1146, Hungary
  • Synexus Debrecen AS
    Debrecen, 4025, Hungary
  • Platán Egészségcentrum
    Eger, 3300, Hungary
  • Synexus Magyarország kft. Gyula DRS
    Gyula, 5700, Hungary
  • Shawfar-med Kft
    Kalocsa, 6300, Hungary
  • Jutrix Kft.
    Kecskemét, 6000, Hungary
  • Bács-Kiskun Megyei Kórház Kiskunfélegyházi Városi Kórház és Rendelőintézet
    Kiskunfélegyháza, 6101, Hungary
  • G&V Pharma-Med Bt.
    Makó, 6901, Hungary
  • Nagyatádi Kórház Reumatológiai Osztály
    Nagyatád, 7500, Hungary
  • Synexus Magyarország EÜ szolg Kft.
    Zalaegerszeg, 8900, Hungary
  • Ambulatorio MMG dott. Paolo Picco
    Sant'Olcese Chiesa, Genova 16010, Italy
  • Ambulatorio MMG dott. Andrea Pedemonte
    Genova, 16162, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Oct 2018, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2020
First posted
Jul 26, 2021
StartActual
May 25, 2018
Primary completionActual
Oct 27, 2018
CompletionActual
Oct 27, 2018
Last update
Oct 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04976088
Lead sponsor
Fidia Farmaceutici s.p.a.
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
May 25, 2018
Primary completion
Oct 27, 2018
Completion
Oct 27, 2018
Last update
Oct 2, 2023

Study contacts

Nicola Giordan
study director · Fidia Farmaceutici s.p.a.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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