NCT00647231

Brief Summary

The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 4, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

March 26, 2008

Last Update Submit

May 12, 2015

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic

Outcome Measures

Primary Outcomes (1)

  • Time to Onset and Duration

    36 hours

Secondary Outcomes (1)

  • Outcome Time Frame

    36 hours

Study Arms (2)

A, 2, II, HKT-500 Topical Patch

EXPERIMENTAL

A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Drug: HKT-500 Topical Patch

Placebo Patch

PLACEBO COMPARATOR

Treatment with placebo patch

Other: Placebo Patch

Interventions

HKT-500 Topical PatchDRUG

Treatment with Ketoprofen Topical Patch

Also known as: HKT-500, Ketoprofen
A, 2, II, HKT-500 Topical Patch
Placebo PatchOTHER

Treatment with placebo patch

Also known as: Sham tratment
Placebo Patch

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female 45 years of age or older
  • with osteoarthritis of the knee

You may not qualify if:

  • subject is a woman of childbearing potential
  • who has a positive urine pregnancy test,
  • is lactating, or who is not surgically sterile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Hisamitsu Investigator Site

Birmingham, Alabama, 35209, United States

Location

Hisamitsu Investigator Site

Phoenix, Arizona, 85013, United States

Location

Hisamitsu Investigator Site

Little Rock, Arkansas, 72205, United States

Location

Hisamitsu Investigator Site

Little Rock, Arkansas, 72211, United States

Location

Hisamitsu Investigator Site

Burbank, California, 91505, United States

Location

Hisamitsu Investigator Site

Escondido, California, 92025, United States

Location

Hisamitsu Investigator Site

Northridge, California, 91325, United States

Location

Hisamitsu Investigator Site

Colorado Springs, Colorado, 80909, United States

Location

Hisamitsu Investigator Site

DeLand, Florida, 32720, United States

Location

Hisamitsu Investigator Site

Hallandale, Florida, 33009, United States

Location

Hisamitsu Investigator Site

Ocala, Florida, 34474, United States

Location

Hisamitsu Investigator Site

Ormond Beach, Florida, 32174, United States

Location

Hisamitsu Investigator Site

Austell, Georgia, 30106, United States

Location

Hisamitsu Investigator Site

Savannah, Georgia, 31405, United States

Location

Hisamitsu Investigator Site

Stockbridge, Georgia, 30281, United States

Location

Hisamitsu Investigator Site

Chicago, Illinois, 60616, United States

Location

Hisamitsu Investigator Site

Madisonville, Kentucky, 42431, United States

Location

Hisamitsu Investigator Site

Baton Rouge, Louisiana, 70809, United States

Location

Hisamitsu Investigator Site

Lake Charles, Louisiana, 70601, United States

Location

Hisamitsu Investigator Site

Flint, Michigan, 48504, United States

Location

Hisamitsu Investigator Site

Omaha, Nebraska, 68114, United States

Location

Hisamitsu Investigator Site

Berlin, New Jersey, 08009, United States

Location

Hisamitsu Investigator Site

Raleigh, North Carolina, 27612, United States

Location

Hisamitsu Investigator Site

Cincinnati, Ohio, 45206, United States

Location

Hisamitsu Investigator Site

Zanesville, Ohio, 43701, United States

Location

Hisamitsu Investigator Site

Oklahoma City, Oklahoma, 73112, United States

Location

Hisamitsu Investigator Site

Duncansville, Pennsylvania, 16635, United States

Location

Hisamitsu Investigator Site

Houston, Texas, 77074, United States

Location

Hisamitsu Investigator Site

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Kenichi Furuta

    Hisamitsu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 4, 2015

Record last verified: 2015-05

Locations

US(29)