Status:
COMPLETED
Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
Lead Sponsor:
Teikoku Seiyaku Co., Ltd.
Collaborating Sponsors:
ClinSearch
CRM Biometrics GmbH
Conditions:
Soft Tissue Injuries
Contusions
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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 blu...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Inclusion criteria
- acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
- location of injury such that pain-on-movement (POM) is elicited on by specified exercises
- enrollment within 6 hours of the injury
- baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
- size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
- adult male or female patients
- age 18 to 60 years
- having given written informed consent
- satisfactory health as determined by the Investigator based on medical history and physical examination.
- Exclusion criteria
- 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
- excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- current skin disorder or shaving hair at application site
- history of excessive sweating/hyperhidrosis inclusive of application site
- intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
- intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
- participation in a clinical study within 30 days before inclusion in the study or concomitantly
- drug or alcohol abuse in the opinion of the investigator
- Pregnant and lactating women
- 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.
Exclusion
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04908748
Start Date
May 20 2021
End Date
December 15 2021
Last Update
September 28 2023
Active Locations (1)
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1
Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
Cologne, North Rhine-Westphalia, Germany, 50933