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

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00211549
First received: September 13, 2005
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: IDEA-033
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IDEA AG:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 875
Study Start Date: June 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211549

  Show 100 Study Locations
Sponsors and Collaborators
IDEA AG
Investigators
Study Director: IDEA AG Clinical Trial IDEA AG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211549     History of Changes
Obsolete Identifiers: NCT00371917
Other Study ID Numbers: CL-033-III-04
Study First Received: September 13, 2005
Last Updated: March 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by IDEA AG:
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014