Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
NCT ID: NCT00485472
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
194 participants
INTERVENTIONAL
2007-03-31
2008-01-31
Brief Summary
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Detailed Description
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The study has an adaptive 3-stage group sequential design.
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.
The study was terminated based on the outcome of the planned 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lacosamide
lacosamide (LCM)
lacosamide
50 or 100mg tablet, 400mg daily, for 12 weeks
Placebo
Placebo
Placebo
50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
Interventions
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lacosamide
50 or 100mg tablet, 400mg daily, for 12 weeks
Placebo
50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).
Exclusion Criteria
* Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
* Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
40 Years
75 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Kladno, , Czechia
Prague, , Czechia
Bad Hersfeld, , Germany
Berlin, , Germany
Hamburg, , Germany
Leipzig, , Germany
München, , Germany
Debrecen, , Hungary
Esztegom, , Hungary
Győr, , Hungary
Gyula, , Hungary
Verseghy, , Hungary
Veszprém, , Hungary
Bialystok, , Poland
Krakow, , Poland
Torun, , Poland
Warsaw, , Poland
Brăila, , Romania
Lasi, , Romania
Târgovişte, , Romania
Timișoara, , Romania
Stockholm, , Sweden
Morriston, , United Kingdom
Newcastle, , United Kingdom
Oxford, , United Kingdom
Stanmore, , United Kingdom
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2006-005048-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0905
Identifier Type: -
Identifier Source: org_study_id
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