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Study on Esflurbiprofen and Paracetamol for Pain Relief in Patients with Limb Bruises

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What is this study about?

This clinical trial is focused on studying the treatment of pain caused by acute contusions, which are bruises that occur on the upper or lower limbs. The treatment being tested is called the Esflurbiprofen Topical System (EFTS), which is a patch applied to the skin. This patch contains a medication called esflurbiprofen, which is designed to help relieve pain locally where the bruise is located. The purpose of the study is to assess the safety and effectiveness of this treatment in providing short-term relief from pain associated with these types of injuries.

Participants in the study will use the Esflurbiprofen Topical System for a period of up to seven days. During this time, the study will monitor how well the treatment works in reducing pain and any side effects that may occur. The study will also compare the effects of the patch to those of a common pain relief medication, paracetamol, which is taken orally in tablet form. The goal is to determine how effective the patch is in comparison to this well-known pain reliever.

Throughout the study, participants will be asked to report their pain levels and any changes they experience. The study will also involve regular check-ins to ensure the treatment is working as intended and to monitor any potential skin reactions to the patch. By the end of the study, researchers hope to gather enough information to understand the benefits and any risks associated with using the Esflurbiprofen Topical System for treating pain from bruises.

1 joining the trial

Upon joining the trial, eligibility is confirmed based on specific criteria such as having an acute contusion of the upper or lower limbs, experiencing pain on movement, and being within 6 hours of injury.

Participants must be adults aged 18 to 64 years and provide written informed consent.

2 initial assessment

An initial assessment is conducted to evaluate the size of the injury, which should be between 25 cm² and 120 cm².

A baseline pain score is recorded using a visual analog scale (VAS) for pain on movement.

3 treatment with esflurbiprofen topical system

The treatment involves the application of the Esflurbiprofen Topical System (EFTS), which is a transdermal patch applied to the skin over the contusion.

The patch is applied topically and is designed to provide local symptomatic relief of pain.

4 oral paracetamol administration

In addition to the topical treatment, Paracetamol is administered orally to help manage pain.

The dosage and frequency of paracetamol are determined by the study protocol and are intended to complement the topical treatment.

5 monitoring and assessments

Participants are monitored for adverse events throughout the trial to ensure safety.

Pain levels are assessed at various intervals, including before bedtime on days 1, 24, 48, 72, 96, 120, and 168 hours, using the VAS for pain on movement and pain at rest.

6 evaluation of treatment effectiveness

The effectiveness of the treatment is evaluated by measuring the time to meaningful and optimal reduction of pain, defined as a 30% and 50% reduction in VAS scores, respectively.

The time to complete resolution of pain on movement and at rest is also recorded.

7 final assessments and conclusion

At the end of the trial, global efficacy assessments are conducted by both the physician and the participant using a 5-point scale.

The trial concludes with a final evaluation of the resolution of contusions and the overall effectiveness of the treatment.

Who Can Join the Study?

  • You must have an acute contusion (a recent bruise) on your upper or lower limbs.
  • The location of your injury should cause pain-on-movement (POM) when you move in a specific way. POM means you feel pain when you move the injured area.
  • You need to join the study within 6 hours of getting the injury.
  • Your VAS score for POM should be more than 50 mm on a 100 mm scale. VAS stands for Visual Analogue Scale, which is a way to measure pain.
  • The size of your injury should be between 25 cm² and 120 cm², as checked by the study doctor.
  • You must be an adult, either male or female.
  • Your age should be between 18 and 64 years old, including those ages.
  • You need to have given written informed consent, which means you agree to participate after understanding the study details.
  • Your overall health should be satisfactory, as determined by the study doctor based on your medical history and a physical check-up.

Who Cannot Join the Study?

  • Individuals with an acute contusion of the upper or lower limbs cannot participate. An acute contusion is a recent bruise or injury to the muscles or tissues.
  • Participants must be within a specific age range, which is not specified here.
  • Both males and females are eligible, but certain groups may be excluded based on other criteria.
  • Vulnerable populations, which may include groups like children, pregnant women, or those unable to consent, might be excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Koo Gtsfv Gilching Germany
Dti mvjx Exhqhq Emepu Bonn Germany
Dyx manh Hhzovr Pcheki chn Sxmaajwtsus Pthy Fürstenfeldbruck Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.01.2025

Trial locations

Investigated drugs:

Esflurbiprofen Topical System (EFTS) is a medication used in this trial to treat pain from contusions. It is applied directly to the skin over the painful area. The goal is to see how safe and effective it is in reducing pain when used for a short period.

Acute Contusion of the Upper or Lower Limbs – This condition involves a bruise or injury to the soft tissue of the arms or legs, typically caused by a direct blow or impact. The affected area may become swollen, tender, and discolored due to bleeding under the skin. Initially, the bruise appears red or purple, gradually changing to blue, green, and yellow as it heals. Pain and stiffness in the affected limb can occur, especially when moving the joint near the contusion. Over time, the swelling and discoloration decrease, and the tissue gradually returns to normal. Recovery can vary depending on the severity of the contusion and the individual’s overall health.

Trial ID:
2024-513064-26-00
Protocol code:
TK-254RX-0302
Trial Phase:
Therapeutic confirmatory (Phase III)

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