Information obtained from ClinicalTrials.gov on May 23, 2013Link to the current ClinicalTrials.gov record.http://clinicaltrials.gov/show/NCT00211549CL-033-III-04NCT00211549NCT00371917An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the KneeA 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 KneeIDEA AGIndustryIDEA AGUnited States: Food and Drug Administration
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.
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
CompletedJune 2005Phase 2InterventionalAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: TreatmentChange 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.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.875Osteoarthritis, KneeDrugIDEA-033
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
Both18 YearsN/ANoIDEA AG Clinical TrialStudy DirectorIDEA AGBirminghamAlabama35209United StatesDrug Research and Analysis CorporationMontgomeryAlabama36124United StatesMontgomeryAlabama36101United StatesNorthportAlabama35476United StatesMesaArizona85206United StatesPhoenixArizona85032United StatesTempeArizona85258United StatesAnaheimCalifornia92801United StatesEncinitasCalifornia92024United StatesFair OaksCalifornia95628United StatesGarden GroveCalifornia92840United StatesIrvineCalifornia92618United StatesParamountCalifornia90723United StatesRancho MirageCalifornia92270United StatesSan DiegoCalifornia92120United StatesSpring ValleyCalifornia91978United StatesTemeculaCalifornia92591United StatesVistaCalifornia92083United StatesNorthglennColorado80234United StatesDanburyConnecticut06810United StatesClearwaterFlorida33761United StatesCoral GablesFlorida33134United StatesDaytona BeachFlorida32114United StatesDelandFlorida32720United StatesFort LauderdaleFlorida33334United StatesFort MyersFlorida33916United StatesGainesvilleFlorida32607United StatesHialeahFlorida33013United StatesJacksonvilleFlorida32216United StatesOcalaFlorida34474United StatesOcalaFlorida34471United StatesOcoeeFlorida34761United StatesPalm HarborFlorida34684United StatesPembroke PinesFlorida33024United StatesPort OrangeFlorida32127United StatesTampaFlorida33614United StatesWest Palm BeachFlorida33409United StatesAtlantaGeorgia30342United StatesAtlantaGeorgia30329United StatesEvansvilleIndiana47714United StatesArkansas CityKansas67005United StatesKansas CityKansas66109United StatesNewtonKansas67114United StatesWichitaKansas67205United StatesLouisvilleKentucky40291United StatesTowsonMaryland21286United StatesMilfordMassachusetts01757United StatesEast LansingMichigan48910United StatesKalamazooMichigan49009United StatesLansingMichigan48917United StatesFlowoodMississippi39232United StatesJacksonMississippi39202United StatesKansas CityMissouri00000United StatesBozemanMontana59715United StatesLas VegasNevada89102United StatesBerlinNew Jersey08009United StatesDoverNew Jersey07801United StatesBinghamtonNew York13901United StatesManilusNew York13104United StatesRochesterNew York14609United StatesDurhamNorth Carolina27704United StatesCumberland Research Associates L L CFayettevilleNorth Carolina28304United StatesWilmingtonNorth Carolina28412United StatesWinston SalemNorth Carolina27103United StatesCommunity Research Managment AssociatesCincinattiOhio45227United StatesCincinnatiOhio45224United StatesCincinnatiOhio45236United StatesCincinnatiOhio45219United StatesColombusOhio43215United StatesColumbusOhio43212United StatesFranklinOhio45005United StatesPerrysburgOhio43551United StatesBethanyOklahoma73008United StatesBeaverPennsylvania15009United StatesBensalemPennsylvania19020United StatesDuncansvillePennsylvania16635United StatesHarleysvillePennsylvania19438United StatesLevittownPennsylvania19057United StatesPenndelPennsylvania19047United StatesPhiladelphiaPennsylvania19152United StatesPittsburghPennsylvania15219United StatesWarwickRhode Island02886United StatesAndersonSouth Carolina29621United StatesCharlestonSouth Carolina29407United StatesColumbiaSouth Carolina29204United StatesGreerSouth Carolina29651United StatesMemphisTennessee38120United StatesAustinTexas78758United StatesDallasTexas75234United StatesDallasTexas75231United StatesDallasTexas75235United StatesHoustonTexas77024United StatesLake JacksonTexas77566United StatesSan AntonioTexas78209United StatesSan AntonioTexas78217United StatesSalt Lake CityUtah84124United StatesSalt Lake CityUtah84102United StatesSpokaneWashington99202United StatesSpokaneWashington99207United StatesGlendaleWisconsin53217United StatesUnited StatesMarch 2009March 19, 2009September 13, 2005OsteoarthritisOsteoarthritisOsteoarthritis, KneeNaproxen