Proof-of-concept Study of NSAID Hydrogel Patch in Treatment of Acute Pain

A Phase II, Randomized, Double-blind, Placebo Controlled, Proof of Concept Study to Investigate the Safety and Efficacy of the Esflurbiprofen Hydrogel Patch in Treatment of Acute Pain Associated With Ankle Injury

The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in comparing with placebo in the treatment of acute pain due to ankle sprain

Study Overview

• Status: Terminated
• Conditions: Ankle Sprain
• Intervention / Treatment: Drug: Esflurbiprofen Hydrogel Patch

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States
      • SNBL Clinical Pharmacology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must be a male or female aged 18 to 65 years, inclusive.
2. Subject must have a diagnosis of uncomplicated acute minor ankle sprain of Grade I or II as defined by the AAOS criteria.
3. Ankle sprain must have occurred <48 hours prior to Screening.
4. Subject must have a baseline self-evaluated pain score of >50 mm on a 100 mm VAS while bearing weight on the affected ankle.
5. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of the study product.
6. Subject must be willing to refrain from using any other pain medication (other than allowed rescue medication) during their participation.

Exclusion Criteria:

1. Subject is a pregnant, breastfeeding, or lactating female.
2. Subject has an acute ankle sprain of Grade III as defined by AAOS criteria.
3. Subject has an ankle fracture as confirmed by X-ray.
4. Ankle sprain requires surgical treatment.
5. Subject has experienced recurrent sprains (≥3 sprains of the same joint) or has sprained the affected joint within the last 12 months.
6. Subject has taken analgesics other than NSAID(s) or acetaminophen for any purpose within 7 days of Screening.
7. Subject has taken flurbiprofen or naproxen within 24 hours of Screening.
8. Ankle sprain is treated prior to Screening by ultrasound, physical therapy, or acupuncture.
9. Subject has used immunomodulators or immunosuppressive therapies (e.g., interferon, oral or parenteral corticosteroids, and cytotoxic drugs) within 4 weeks prior to randomization.
10. Subject has used any medicated topical agents (e.g., medicated creams or lotions) on the affected ankle within 7 days prior to Screening.
11. Subject is currently using any other medications that, in the opinion of the Investigator, may exacerbate or mask the anticipated side effects of NSAIDs or interfere with the Investigator's ability to monitor for them (e.g., blood thinners or proton-pump inhibitors).
12. Subject has non-intact or damaged skin in the area to be treated (e.g., eczema, psoriasis, exudative dermatitis, infected lesion, burn, or wound).
13. Subject has a history of ulcers, GI bleeding, hypertension, edema, heart failure, or CV disease.

14. Subject has asthma (except childhood asthma), urticaria, angioedema, or bronchospasm.

    a.A subject is eligible for the study if they have had no symptoms of these conditions that required medication in the 5 years prior to Screening.

15. Subject has a history of any chronic pain disorder.
16. Subject has coagulation defects.
17. Subject has a history of severe cardiac, renal, or hepatic impairment within 12 months prior to Screening that, in the opinion of the Investigator, would interfere with the outcome of the study.
18. Subject has a severe systemic disease (e.g., cancer or severe acute infection).
19. Subject has a known allergy or hypersensitivity to flurbiprofen, aspirin, other NSAID(s), or any excipient in the IP.
20. Subject has any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
21. Subject has a history of uncontrolled chronic or acute concomitant disease that, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results.
22. Subject has applied ice or compression to the affected ankle within 2 hours prior to Screening.
23. Subject has a bilateral ankle injury.
24. Subject has an ipsilateral knee injury. In the opinion of the Investigator, are unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Esflurbiprofen 1.5% Hydrogel Patch; One patch per 24hr for 7 days	Drug: Esflurbiprofen Hydrogel Patch; One patch per day for 7 days
Placebo Comparator: Placebo comparator; Placebo One patch per 24hr for 7 days	Drug: Esflurbiprofen Hydrogel Patch; One patch per day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of intensity of pain difference after 48hr treatment (SPID48h)	SPID48h will be compared between EFHP and placebo.	48hr after treatment starting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID24h	Sum of intensity (VAS) of pain difference after 24hr	24hr after treatment starting

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID72h	Sum of intensity (VAS) of pain difference after 72hr was measured	72hr after treatment starting

Collaborators and Investigators

• Sponsor: Teikoku Seiyaku Co., Ltd.
• Investigators: Principal Investigator: Masaru Kaneko, MD, SNBL Clinical Pharmacology Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 21, 2016
• Study Completion (Actual): December 27, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: NSAID Patch
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Acute Pain; Ankle Injuries
• Other Study ID Numbers: TS-TK-254-US0200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No