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Osteoarthritis, KneePhase 2NCT00265304

A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee

A Phase 2 study testing Ketoprofen in people with Osteoarthritis, Knee, run by IDEA AG at 93 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 evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees. 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?
Ketoprofen
How many people
550 participants
Where
93 sitesUnited States
Study dates
Jul 2005to Jul 2007
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

  • Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of efficacy
  • Patients who did not complete or discontinue from Study 17-007 must have osteoarthritis of both knees for a minimum of six months
  • Have moderate pain in the most involved knee when not taking non-steroidal anti-inflammatory drugs (NSAIDs)
  • Must have used an oral NSAID on at least three days per week for the last three months, or 25 of the 30 days before screening
  • Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Who cannot join

  • Any patient currently receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would compromise the ability of the subject to complete the required assessments and visits
  • For patients who did not participate in Study 17-007: having Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
  • Received intra-articular injections or arthroscopy of the most involved knee during three months before screening visit
  • Have a large bulging effusion, or have inflammation of the most involved knee that could be related to gout, pseudogout-induced synovitis, or infection
  • Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

United States93 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Arkansas City, Kansas, 67005

  • International Research Center

    Atlanta, Georgia, 21286

  • 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

  • Gilbert Medical Research

    Bethany, Oklahoma, 73008

  • Study site

    Binghamton, New York, 13901

  • Capstone Clinical Trials Inc

    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

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Columbus, Ohio, 43215

  • 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

  • Radiant Research-daytona

    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

  • Study site

    Flowood, Mississippi, 39232

  • 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

  • The Community Research of South Florida

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77024

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Kalamazoo, Michigan, 49009

  • 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

  • Study site

    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

    Tempe, Arizona, 85258

  • 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

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Double-Blind, Long-Term Evaluation of the Safety 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 evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.

Read the detailed description

This is a double-blind, active-controlled study of the safety of IDEA-033 in comparison to oral naproxen for the treatment of the signs and symptoms of osteoarthritis of the knee in patients who have completed Study 17-007 or who have discontinued Study 17-007 due to lack of efficacy. If a sufficient number of patients do not enroll from Study 17-007, patients with osteoarthritis of both knees who were not enrolled in Study 17-007 may be enrolled in this study. Patients treated with IDEA-033 in Study 17-007 will receive 100 mg per knee of ketoprofen gel twice daily and one placebo capsule twice daily for 52 weeks. Patients treated with oral naproxen or placebo in Study 17-007 will receive a 500 mg naproxen over-encapsulated tablet twice daily and placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments. The primary outcomes of the study include the incidence and severity of adverse events, dermal-irritation scores, and changes in routine clinical laboratory tests and vital signs obtained at each visit.

Patients assigned to IDEA-033 in Study 17-007 will topically apply 100 mg per knee of ketoprofen gel twice daily and take one oral placebo capsule twice daily for 52 weeks. Patients assigned to oral naproxen or placebo in Study 17-007 will take one 500 mg naproxen over-encapsulated tablet orally twice daily and apply placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments.

Being tested
Ketoprofen
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.

  • KetoprofenDrug

What is being measured

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

  1. Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit.

Secondary outcomes (1)

  1. Change from baseline (Week 12 for patients who completed 17-007, baseline for those who did not) and mean value per visit for WOMAC pain, stiffness, and physical function scores; Subject Global Assessment of Response to Therapy.

Timeline

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

  1. First posted14 Dec 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2007

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
550 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00265304
Sponsor's protocol ID
CL-033-III-05
Status last verified
Mar 2009
First submitted
13 Dec 2005
Last updated
20 Mar 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketoprofen in people with Osteoarthritis, Knee, run by IDEA AG at 93 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 5 inclusion and 5 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 93 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?

Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit.. 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 NCT00265304.

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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