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HKT-500 in Adult Patients With Ankle Sprain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680784
First Posted: May 20, 2008
Last Update Posted: June 4, 2015
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.
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
May 16, 2008
May 20, 2008
June 4, 2015
April 2008
November 2008   (Final data collection date for primary outcome measure)
Pain Assessment [ Time Frame: 2 Weeks ]
Same as current
Complete list of historical versions of study NCT00680784 on ClinicalTrials.gov Archive Site
Safety Assessment [ Time Frame: 2 Weeks ]
Same as current
Not Provided
Not Provided
 
HKT-500 in Adult Patients With Ankle Sprain
Protocol HKT-500-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Ankle Sprain
  • Drug: HKT-500 Ketoprofen Topical Patch
    HKT-500 Ketoprofen Topical Patch
    Other Name: Ketoprofen Topical Patch
  • Other: Placebo Patch
    Placebo Patch
    Other Name: Sham treatment
  • Experimental: HKT-500 Ketoprofen Topical Patch
    Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.
    Intervention: Drug: HKT-500 Ketoprofen Topical Patch
  • Placebo Comparator: Placebo Patch
    Treatment with placebo patch
    Intervention: Other: Placebo Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Grade I or Grade II Ankle Sprain.

Exclusion Criteria:

  • The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00680784
HKT-500-US10
Yes
Not Provided
Not Provided
Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
Not Provided
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
May 2015

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