Clinical Trial: Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries

Brief Summary: The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.

Detailed Summary:
Sponsor: IBSA Institut Biochimique SA

Current Primary Outcome: Dermatologic assessment at the patch application site [ Time Frame: Up to 2 weeks, depending upon pain resolution ]

None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Investigator assessment of the global response to therapy on a 5-point scale [ Time Frame: Up to 2 weeks, depending upon pain resolution ]
    5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5.
  • Patient assessment of pain on a 6-point scale [ Time Frame: Up to 2 weeks, depending upon pain resolution ]

    Wong-Baker Faces Scale 6-point scale:

    No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5.

  • Plasma concentration of diclofenac [ Time Frame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution ]


Original Secondary Outcome: Same as current

Information By: IBSA Institut Biochimique SA

Dates:
Date Received: April 28, 2014
Date Started: May 2014
Date Completion: April 2017
Last Updated: March 6, 2017
Last Verified: March 2017