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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Esflurbiprofen Topical System – This medication is applied directly to the skin as a topical system, specifically designed for local use. It is currently being studied in clinical trials to evaluate its safety and effectiveness in treating pain associated with acute contusions of the upper or lower limbs. The main therapeutic indication is the short-term relief of pain in these injuries. Esflurbiprofen works by inhibiting the production of certain chemicals in the body that cause inflammation and pain. It belongs to the pharmacological class of nonsteroidal anti-inflammatory drugs (NSAIDs).

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513064-26-00Protocol codeTK-254RX-0302Estimated enrolment219 patientsSponsorTeikoku Seiyaku Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).