Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485472
Status:
TERMINATED
Last Update Posted:
2017-08-28
First Post:
2007-06-12
Brief Title:
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Trial to Assess the Efficacy and Safety of 400mgDay Lacosamide in Subjects With Osteoarthritis of the Knee
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on the outcome of the planned first interim analysis it was decided not to continue the trial No safety concerns were identified
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate the effectiveness safety and tolerability of lacosamide LCM 400mgday in treating the signs and symptoms of osteoarthritis of the knee
Detailed Description:
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 andor paracetamol This trial will be conducted exclusively in Europe
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 400mgday 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
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 400mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005048-97 | EUDRACT_NUMBER | None | None |