Clinical trial NCT00927641: HKT-500 in the Treatment of Adult Patients With Ankle Sprain
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankle Sprain
Keywords: Ankle Sprain
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Eligibility criteria: Inclusion Criteria:

* mild to Moderate Ankle Sprain

Exclusion Criteria:

* Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced 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: Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)
timeFrame: 3 days + 1
Secondary outcomes:
measure: Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction
timeFrame: 14 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Tucson
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Hot Springs
country: United States
facility: Hisamitsu Investigator Site
state: Arkansas
city: Anaheim
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Anaheim
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Buena Park
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Long Beach
country: United States
facility: Hisamitsu Investigator Site
state: California
city: San Diego
country: United States
facility: Hisamitsu Investigator Site
state: California
city: San Luis Obispo
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Daytona Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Hialeah
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Jacksonville
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Oldsmar
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Ormond Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: South Miami
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Evansville
country: United States
facility: Hisamitsu Investigator Site
state: Indiana
city: Omaha
country: United States
facility: Hisamitsu Investigator Site
state: Nebraska
city: Blackwood
country: United States
facility: Hisamitsu Investigator Site
state: New Jersey
city: South Bound Brook
country: United States
facility: Hisamitsu Investigator Site
state: New Jersey
city: Johnson City
country: United States
facility: Hisamitsu Investigator Site
state: Tennessee
city: Dallas
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: West Valley City
country: United States
facility: Hisamitsu Investigator Site
state: Utah
city: Danville
country: United States
facility: Hisamitsu Investigator Site
state: Virginia
Study officials:
References: