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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00485472 |
Lacosamide (LCM) is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of LCM taken orally twice a day for about 3 months.
The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.
The last subject is expected to be enrolled in December 2007.
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: lacosamide |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Study Start Date: | March 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Based on the outcome of a first interim analysis, which was performed as defined in the protocol in a subset of patients, it was decided not to continue the trial. No safety concerns were identified.
The Company remains committed to the program and is going to undertake a thorough analysis of the full clinical data set.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
Prague, Czech Republic | |
Kladno, Czech Republic | |
Germany | |
Hamburg, Germany | |
München, Germany | |
Leipzig, Germany | |
Berlin, Germany | |
Bad Hersfeld, Germany | |
Hungary | |
Gyula, Hungary | |
Esztegom, Hungary | |
Debrecen, Hungary | |
Verseghy, Hungary | |
Veszprem, Hungary | |
Gyor, Hungary | |
Poland | |
Krakow, Poland | |
Bialystok, Poland | |
Warszawa, Poland | |
Torun, Poland | |
Romania | |
Braila, Romania | |
Timisoara, Romania | |
Targoviste, Romania | |
Lasi, Romania | |
Sweden | |
Stockholm, Sweden | |
United Kingdom | |
Stanmore, United Kingdom | |
Newcastle, United Kingdom | |
Oxford, United Kingdom | |
Morriston, United Kingdom |
Study Director: | Tony Daniels | Schwarz Biosciences Inc. |
Study ID Numbers: | SP905 |
Study First Received: | June 12, 2007 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00485472 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |