Clinical trial NCT00211549: An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 875
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 purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

Detailed description: The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain, WOMAC Physical Function, and Subject Global Assessment of Response to Therapy. A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033.

Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of both knees for minimum of six months
* Moderate pain in the most involved knee when not taking NSAIDs
* Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Exclusion Criteria:

* Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
* Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
* Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
* A large bulging effusion
* History of gout or pseudo-gout induced synovitis or infection of the more severe knee
* History of partial or total knee replacement in either knee

Primary outcomes:
measure: Change from baseline at Week 12 on pain subscale and physical function subscale on the WOMAC Osteoarthritis Index. Subject global assessment of response to therapy (SGART) on a five-point Likert scale at Week 12.
Secondary outcomes:
measure: Change from baseline at Weeks 2, 6, 9 for WOMAC pain and physical function scores and SGART. Mean change from baseline for the entire on-therapy period for WOMAC pain and physical function scores and SGART.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corporation
state: Alabama
city: Northport
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Fair Oaks
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Irvine
country: United States
state: California
city: Paramount
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Diego
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Temecula
country: United States
state: California
city: Vista
country: United States
state: California
city: Northglenn
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ocoee
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Arkansas City
country: United States
state: Kansas
city: Kansas City
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Towson
country: United States
state: Maryland
city: Milford
country: United States
state: Massachusetts
city: East Lansing
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Flowood
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Dover
country: United States
state: New Jersey
city: Binghamton
country: United States
state: New York
city: Manilus
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates L L C
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinatti
country: United States
facility: Community Research Managment Associates
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Colombus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Beaver
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Levittown
country: United States
state: Pennsylvania
city: Penndel
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Glendale
country: United States
state: Wisconsin
Study officials:
affiliation: IDEA AG
name: IDEA AG Clinical Trial
role: STUDY_DIRECTOR
References: