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

NCT02729207 | Terminated Phase 2 DMC

• 1 other identifier: TS-TK-254-US0200
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankle Sprain

Keywords

NSAID Patch

Outcome Measures

Primary Outcomes (1)

• Sum of intensity of pain difference after 48hr treatment (SPID48h)

  SPID48h will be compared between EFHP and placebo.

  48hr after treatment starting

Secondary Outcomes (1)

• SPID24h

  24hr after treatment starting

Other Outcomes (1)

• SPID72h

  72hr after treatment starting

Study Arms (2)

Esflurbiprofen 1.5% Hydrogel Patch

ACTIVE COMPARATOR

One patch per 24hr for 7 days

Drug: Esflurbiprofen Hydrogel Patch

Placebo comparator

PLACEBO COMPARATOR

Placebo One patch per 24hr for 7 days

Drug: Esflurbiprofen Hydrogel Patch

Interventions

Esflurbiprofen Hydrogel Patch DRUG

One patch per day for 7 days

Esflurbiprofen 1.5% Hydrogel Patch; Placebo comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be a male or female aged 18 to 65 years, inclusive.
• Subject must have a diagnosis of uncomplicated acute minor ankle sprain of Grade I or II as defined by the AAOS criteria.
• Ankle sprain must have occurred \<48 hours prior to Screening.
• Subject must have a baseline self-evaluated pain score of \>50 mm on a 100 mm VAS while bearing weight on the affected ankle.
• 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.
• Subject must be willing to refrain from using any other pain medication (other than allowed rescue medication) during their participation.

You may not qualify if:

• Subject is a pregnant, breastfeeding, or lactating female.
• Subject has an acute ankle sprain of Grade III as defined by AAOS criteria.
• Subject has an ankle fracture as confirmed by X-ray.
• Ankle sprain requires surgical treatment.
• Subject has experienced recurrent sprains (≥3 sprains of the same joint) or has sprained the affected joint within the last 12 months.
• Subject has taken analgesics other than NSAID(s) or acetaminophen for any purpose within 7 days of Screening.
• Subject has taken flurbiprofen or naproxen within 24 hours of Screening.
• Ankle sprain is treated prior to Screening by ultrasound, physical therapy, or acupuncture.
• Subject has used immunomodulators or immunosuppressive therapies (e.g., interferon, oral or parenteral corticosteroids, and cytotoxic drugs) within 4 weeks prior to randomization.
• Subject has used any medicated topical agents (e.g., medicated creams or lotions) on the affected ankle within 7 days prior to Screening.
• 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).
• Subject has non-intact or damaged skin in the area to be treated (e.g., eczema, psoriasis, exudative dermatitis, infected lesion, burn, or wound).
• Subject has a history of ulcers, GI bleeding, hypertension, edema, heart failure, or CV disease.
• 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.

Sponsors & Collaborators

• Teikoku Seiyaku Co., Ltd.: lead

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Masaru Kaneko, MD

  SNBL Clinical Pharmacology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 6, 2016
• Study Start: July 1, 2016
• Primary Completion: December 21, 2016
• Study Completion: December 27, 2016
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)