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

NCT04908748 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TK-254R-0201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Soft Tissue Injuries; Contusions; Strains; Sprains; Bruises

Keywords

Blunt Trauma

Outcome Measures

Primary Outcomes (1)

• Change of Pain-on-movement (POM) Compared to Baseline

  Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

  Change from baseline to Visit 5 (72 hours after initiating treatment)

Secondary Outcomes (13)

• Pain-on-movement (POM) on VAS

  Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

• Area-under-the-curve for POM on VAS

  Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

• Pain-at-rest on VAS

  Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

• Time to Meaningful and Optimal Reduction

  Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment

• Time to Complete Resolution of Pain

  Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment

Other Outcomes (2)

• Adhesive Power of the Patch

  12h for day 1, 24h for day 1-5 and 7 after application of each patch

• Local Tolerability

  24, 48, 72, 96, 168h

Study Arms (2)

Active Arm

EXPERIMENTAL

Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen

Drug: Esflurbiprofen Hydrogel Patch

Control Drug

PLACEBO COMPARATOR

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

Drug: Esflurbiprofen Hydrogel Patch

Interventions

Esflurbiprofen Hydrogel Patch DRUG

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Active Arm; Control Drug

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• current skin disorder or shaving hair at application site
• history of excessive sweating/hyperhidrosis inclusive of application site
• intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
• 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.

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead
• ClinSearch: collaborator
• CRM Biometrics GmbH: collaborator
• Clinigen, Inc.: collaborator

Study Sites (1)

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin

Cologne, North Rhine-Westphalia, 50933, Germany

Location

MeSH Terms

Conditions

Soft Tissue Injuries; Contusions; Sprains and Strains; Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Hirofumi Fujiwara
• Organization: Teikoku Seiyaku Co.,Ltd.

hirofumi-fujiwara@teiyaku.co.jp

+81362649123

Study Officials

• Hiroshi Aoki

  Teikoku Seiyaku Co., Ltd.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, double-blind, multi-center

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 1, 2021
• Study Start: May 20, 2021
• Primary Completion: November 9, 2021
• Study Completion: December 15, 2021
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)