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FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01037816
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.

Tracking Information
First Submitted Date  ICMJE December 18, 2009
First Posted Date  ICMJE December 23, 2009
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE December 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
Primary: Sum of Pain Intensity Difference at 8-hours (SPID8) upon monopodal weight bearing. [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2009)
SPID8 at rest; PID8; SPID12, SPID20, SPID44, and SPID68 at rest and upon monopodal weight bearing. [ Time Frame: 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
Brief Summary 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).
Detailed Description A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Drug: FS-67 Patch
    One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
    Other Name: Topical Patch
  • Other: Placebo Patch
    One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
    Other Name: Sham treatment
Study Arms  ICMJE
  • Active Comparator: FS-67 patch
    One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
    Intervention: Drug: FS-67 Patch
  • Placebo Comparator: Placebo Patch
    One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
    Intervention: Other: Placebo Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
252
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2009)
300
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Grade 1 or Grade 2 ankle sprain

Exclusion Criteria:

  • Pregnancy or lactation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01037816
Other Study ID Numbers  ICMJE FS-67-HP01-E02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hisamitsu Pharmaceutical Co., Inc.
Study Sponsor  ICMJE Hisamitsu Pharmaceutical Co., Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hisamitsu Pharmaceutical Co., Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP