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Osteoarthritis, KneePhase 2NCT00211549

An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

A Phase 2 study testing IDEA-033 in people with Osteoarthritis, Knee, run by IDEA AG at 100 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
IDEA-033
How many people
875 participants
Where
100 sitesUnited States
Study dates
Jun 2005to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78758

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Bethany, Oklahoma, 73008

  • Study site

    Binghamton, New York, 13901

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Bozeman, Montana, 59715

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45224

  • Community Research Managment Associates

    Cincinnati, Ohio, 45227

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Colombus, Ohio, 43215

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75234

  • Study site

    Dallas, Texas, 75235

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    DeLand, Florida, 32720

  • Study site

    Dover, New Jersey, 07801

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Durham, North Carolina, 27704

  • Study site

    East Lansing, Michigan, 48910

  • Study site

    Encinitas, California, 92024

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fair Oaks, California, 95628

  • Cumberland Research Associates L L C

    Fayetteville, North Carolina, 28304

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Garden Grove, California, 92840

  • Study site

    Glendale, Wisconsin, 53217

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77024

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kansas City, Kansas, 66109

  • Study site

    Kansas City, Missouri, 00000

  • Study site

    Lake Jackson, Texas, 77566

  • Study site

    Lansing, Michigan, 48917

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Levittown, Pennsylvania, 19057

  • Study site

    Louisville, Kentucky, 40291

  • Study site

    Manilus, New York, 13104

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Milford, Massachusetts, 01757

  • Study site

    Montgomery, Alabama, 36101

  • Drug Research and Analysis Corporation

    Montgomery, Alabama, 36124

  • Study site

    Newton, Kansas, 67114

  • Study site

    Northglenn, Colorado, 80234

  • Study site

    Northport, Alabama, 35476

  • Study site

    Ocala, Florida, 34471

  • Study site

    Ocala, Florida, 34474

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Paramount, California, 90723

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Penndel, Pennsylvania, 19047

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Philadelphia, Pennsylvania, 19152

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Pittsburgh, Pennsylvania, 15219

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Rochester, New York, 14609

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    Salt Lake City, Utah, 84124

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Antonio, Texas, 78217

  • Study site

    San Diego, California, 92120

  • Study site

    Spokane, Washington, 99202

  • Study site

    Spokane, Washington, 99207

  • Study site

    Spring Valley, California, 91978

  • Study site

    Tampa, Florida, 33614

  • Study site

    Temecula, California, 92591

  • Study site

    Tempe, Arizona, 85258

  • Study site

    Towson, Maryland, 21286

  • Study site

    Vista, California, 92083

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Wilmington, North Carolina, 28412

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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

Being tested
IDEA-033
Keywords
Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDEA-033Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
875 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00211549
Sponsor's protocol ID
CL-033-III-04
Status last verified
Mar 2009
First submitted
13 Sep 2005
Last updated
20 Mar 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IDEA-033 in people with Osteoarthritis, Knee, run by IDEA AG at 100 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00211549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.

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