HKT-500 in Adult Patients With Ankle Sprain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00680784
First received: May 16, 2008
Last updated: August 18, 2014
Last verified: August 2014

May 16, 2008
August 18, 2014
April 2008
November 2008   (final data collection date for primary outcome measure)
Pain Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680784 on ClinicalTrials.gov Archive Site
Safety Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Ankle Sprain
  • Drug: HKT-500 & Ketoprofen Topical Patch
    HKT-500 & Ketoprofen Topical Patch
    Other Name: Ketoprofen Topical Patch
  • Drug: placebo
    placebo
    Other Name: Ketoprofen Topical Patch
  • Experimental: 1
    A Randomized, Multi-Center, Double-Blind
    Intervention: Drug: HKT-500 & Ketoprofen Topical Patch
  • Placebo Comparator: 2
    Intervention: Drug: placebo
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680784
HKT-500-US10
Yes
Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
Not Provided
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
August 2014

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