Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2021-12-15

Brief Summary

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Objective of this study is:

to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.

to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

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Detailed Description

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Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites

The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria.

200 patients will be enrolled (assumes a drop-out-rate of ≤10%).

The study will be performed in Germany in 3 sites

Conditions

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Soft Tissue Injuries Contusions Strains Sprains Bruises

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, double-blind, multi-center

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Packages of Investigative Medicinal product will be non-distinguishable to patients, study site staff and monitors.

Randomization data are kept strictly confidential, accessible only to authorized persons, until the time of unblinding the identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance and odor.

Unblinding will only occur in the case of patient emergencies and at the conclusion of the study.

Study Groups

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Active Arm

Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen

Group Type EXPERIMENTAL

Esflurbiprofen Hydrogel Patch

Intervention Type DRUG

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Control Drug

Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch

Group Type PLACEBO_COMPARATOR

Esflurbiprofen Hydrogel Patch

Intervention Type DRUG

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Interventions

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Esflurbiprofen Hydrogel Patch

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
2. location of injury such that pain-on-movement (POM) is elicited on by specified exercises
3. enrollment within 6 hours of the injury
4. baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
6. adult male or female patients
7. age 18 to 60 years
8. having given written informed consent
9. satisfactory health as determined by the Investigator based on medical history and physical examination.

Exclusion Criteria

1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
3. current skin disorder or shaving hair at application site
4. history of excessive sweating/hyperhidrosis inclusive of application site
5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
7. participation in a clinical study within 30 days before inclusion in the study or concomitantly
8. drug or alcohol abuse in the opinion of the investigator
9. Pregnant and lactating women
10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:

* Surgical sterilization
* Hormonal contraception
* Intra Uterine Device
* Double barrier method
* Total abstinence throughout the study at the discretion of the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No