A study to evaluate efficacy and safety of an Esflurbiprofen Hydrogel Patch vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries

Phase 1

• Conditions: Acute strains, sprains or bruises of the extremities following blunt trauma; MedDRA version: 20.0Level: LLTClassification code 10002549Term: Ankle sprainSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10002550Term: Ankle sprains and strainsSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10028338Term: Muscle sprainsSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10028361Term: Muscular painSystem Organ Class: 100000004859; MedDRA version: 21.1Level: LLTClassification code 10028362Term: Muscular painsSystem Organ Class: 100000004859; MedDRA version: 20.1Level: LLTClassification code 10006502Term: BruiseSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-005165-14-DE
• Lead Sponsor: Teikoku Seiyaku Co Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-11
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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 the exercises described in Section 7.5
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.
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
•IUD
•Double barrier method
Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
11.known hypersensitivity to Esflurbiprofen or one of the excipients of the patch
12.patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen
13.history of previous significant injury to the same extremity within 6 months
14.patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc.
15.patients having an ongoing painful condition associated with sports-related injury/contusion
16.patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs
17.patients who had surgery of the affected upper or lower limb within one year of study entry
18.patients with significant diseases (defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease).
19.patients with a blood coagulation disorder
20.patients who use any impermissible medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
•IUD
•Double barrier method
•Total abstinence throughout the study at the discretion of the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified