NCT01037816 is a Phase 4 clinical trial of FS-67 Patch in Ankle Sprain, sponsored by Hisamitsu Pharmaceutical Co., Inc..

Who is sponsoring NCT01037816?

NCT01037816 is sponsored by Hisamitsu Pharmaceutical Co., Inc..

What drugs are being tested in NCT01037816?

Interventions in NCT01037816: FS-67 Patch, Placebo Patch.

What condition does NCT01037816 study?

NCT01037816 studies Ankle Sprain.

Is NCT01037816 still recruiting?

NCT01037816 is currently completed. Last updated 9 September 2022.

Are results published for NCT01037816?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-09 · How we verify

NCT01037816

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Completed Phase 4 Results posted Last updated 9 September 2022

What this trial tests

Phase 4 trial testing FS-67 Patch in Ankle Sprain in 252 participants. Completed in 1 December 2010.

Timeline

1 December 2009

Primary endpoint
1 November 2010

1 December 2010

Quick facts

Lead sponsor	Hisamitsu Pharmaceutical Co., Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	252
Start date	1 December 2009
Primary completion	1 November 2010
Estimated completion	1 December 2010
Sites	23 locations across United States

Drugs / interventions tested

FS-67 Patch — full drug profile →
Placebo Patch

Conditions studied

Ankle Sprain — all drugs for Ankle Sprain →

Sponsor

Hisamitsu Pharmaceutical Co., Inc. — full company profile →

Who can join

Adults 13 to 17, any sex, with Ankle Sprain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Time frame: 8 hours of patch application on Day 1
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time

Sponsor's own description

The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ankle Sprain

Currently open trials in the same condition.

NCT07190599 — NMES With PNF for Ankle Sprain Rehabilitation · NA · recruiting
NCT07154433 — A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery · NA · recruiting
NCT07200271 — Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction o · NA · recruiting
NCT07025733 — Semiconductor Embedded Socks for Ankle Sprains · NA · recruiting
NCT06623929 — Topical Treatments for Ankle Sprains · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01037816 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hisamitsu Pharmaceutical Co., Inc.
Last refreshed: 9 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01037816.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing