Clinical trial NCT00680784: HKT-500 in Adult Patients With Ankle Sprain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprain
Keywords: sprain
ankle
pain
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Assessment
timeFrame: 2 Weeks
Secondary outcomes:
measure: Safety Assessment
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site.
state: Alabama
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site.
state: Alabama
city: Montgomery
country: United States
facility: Hisamitsu Investigator Site.
state: Alabama
city: Anaheim
country: United States
facility: Hisamitsu Investigator Site.
state: California
city: San Luis Obispo
country: United States
facility: Hisamitsu Investigator Site.
state: California
city: Colorado Springs
country: United States
facility: Hisamitsu Investigator Site.
state: Colorado
city: Kissimmee
country: United States
facility: Hisamitsu Investigator Site.
state: Florida
city: Oldsmar
country: United States
facility: Hisamitsu Investigator Site.
state: Florida
city: Pembroke Pines
country: United States
facility: Hisamitsu Investigator Site.
state: Florida
city: South Miami
country: United States
facility: Hisamitsu Investigator Site.
state: Florida
city: Blue Ridge
country: United States
facility: Hisamitsu Investigator Site.
state: Georgia
city: Chicago
country: United States
facility: Hisamitsu Investigator Site.
state: Illinois
city: Paducah
country: United States
facility: Hisamitsu Investigator Site.
state: Kentucky
city: Pasadena
country: United States
facility: Hisamitsu Investigator Site.
state: Maryland
city: Benzonia
country: United States
facility: Hisamitsu Investigator Site.
state: Michigan
city: Cadillac
country: United States
facility: Hisamitsu Investigator Site.
state: Michigan
city: Interlochen
country: United States
facility: Hisamitsu Investigator Site.
state: Michigan
city: Kalamazoo
country: United States
facility: Hisamitsu Investigator Site.
state: Michigan
city: Omaha
country: United States
facility: Hisamitsu Investigator Site.
state: Nebraska
city: South Bound Brook
country: United States
facility: Hisamitsu Investigator Site.
state: New Jersey
city: Albuquerque
country: United States
facility: Hisamitsu Investigator Site.
state: New Mexico
city: New York
country: United States
facility: Hisamitsu Investigator Site.
state: New York
city: Fargo
country: United States
facility: Hisamitsu Investigator Site.
state: North Dakota
city: Zanesville
country: United States
facility: Hisamitsu Investigator Site.
state: Ohio
city: Altoona
country: United States
facility: Hisamitsu Investigator Site.
state: Pennsylvania
city: Feasterville
country: United States
facility: Hisamitsu Investigator Site.
state: Pennsylvania
city: Morrisville
country: United States
facility: Hisamitsu Investigator Site.
state: Pennsylvania
city: Norristown
country: United States
facility: Hisamitsu Investigator Site.
state: Pennsylvania
city: Houston
country: United States
facility: Hisamitsu Investigator Site.
state: Texas
city: Bellevue
country: United States
facility: Hisamitsu Investigator Site.
state: Washington
Study officials:
affiliation: Hisamitsu Pharmaceutical Co., Inc.
name: Kenichi Furuta
role: STUDY_DIRECTOR
References: