Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
NCT ID: NCT00878501
Last Updated: 2012-06-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
241 participants
INTERVENTIONAL
2009-03-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD1386, 90 mg
AZD1386
oral, during 4 weeks
AZD1386, 30 mg
AZD1386
oral, during 4 weeks
Placebo
Placebo
Oral, during 4 weeks
Interventions
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AZD1386
oral, during 4 weeks
AZD1386
oral, during 4 weeks
Placebo
Oral, during 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Male or non pregnant females 40 and 80 years old
Exclusion Criteria
* History, and/or presence of somatic disease, which may interfere with the objectives
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Richard L Leff, MD
Role: STUDY_DIRECTOR
AZD1386AstraZeneca R&D Wilmington, USA
Ola Svensson, MD
Role: STUDY_CHAIR
AZD1386AstraZeneca R&D Södertälje, Sweden
Locations
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Research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
St. Catharines, Ontario, Canada
Research Site
Charlottetown, Prince Edward Island, Canada
Research Site
Saint Romuald, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Helsinki, , Finland
Research Site
Hyvinkää, , Finland
Research Site
Lahti, , Finland
Research Site
Riihimäki, , Finland
Research Site
Tampere, , Finland
Research Site
Vantaa, , Finland
Research Site
Békéscsaba, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Veszprém, , Hungary
Research Site
Japan, , Japan
Research Site
Bialystok, , Poland
Research Site
Elblag, , Poland
Research Site
Gdynia, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Toru, , Poland
Research Site
Warsaw, , Poland
Research Site
Brastislava, , Slovakia
Research Site
Komárno, , Slovakia
Research Site
Liptovský Hrádok, , Slovakia
Research Site
Poprad, , Slovakia
Research Site
Považská Bystrica, , Slovakia
Research Site
Rimavská Sobota, , Slovakia
Research Site
Žiar nad Hronom, , Slovakia
Research Site
Žilina, , Slovakia
Countries
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References
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Miller F, Bjornsson M, Svensson O, Karlsten R. Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis. Contemp Clin Trials. 2014 Mar;37(2):189-99. doi: 10.1016/j.cct.2013.12.007. Epub 2014 Jan 3.
Other Identifiers
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D5090C00019
Identifier Type: -
Identifier Source: org_study_id
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