Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01933919
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2013-08-29
Brief Title:
A Phase 3 Study of Fluvoxamine SME3110 in PediatricAdolescent Patients With Obsessive Compulsive Disorder
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3 Study of SME3110 Fluvoxamine Maleate in PediatricAdolescent Subjects With Obsessive Compulsive Disorder
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Childrens Yale-Brown Obsessive Compulsive Scale JCY-BOCS 10-item from baseline to the last observation visit 10 weeks in pediatricadolescent participants with obsessive compulsive disorder OCD
The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatricadolescent patients with OCD
The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatricadolescent patients with OCD
Detailed Description:
The first phase will be conducted in a randomized placebo-controlled double-blind manner to evaluate the efficacy of fluvoxamine on change from baseline to the last observation visit in the JCY-BOCS 10-item total score Eligible patients will be allocated to the fluvoxamine group or placebo group in a 11 ratio using the experience of fluvoxamine treatment and age as stratification factors dynamic allocation The first phase consists of a screening period of 1-2 weeks a forced titration dose period of 2 weeks a dose adjustment period of 4 weeks a maintained dose period of 4 weeks and a tapering dose period of 0-4 weeks
The 2nd phase will be conducted in an open-label manner in participants who completed the first phase to evaluate the long-term safety of fluvoxamine The 2nd phase consists of 3 periods a forced titration dose period of 2 weeks a flexible dose period of 50 weeks and a tapering dose period of 0-4 weeks After the last dose of study drug including tapering dose period or the early termination visit participants will be followed for up to 30 days
The 2nd phase will be conducted in an open-label manner in participants who completed the first phase to evaluate the long-term safety of fluvoxamine The 2nd phase consists of 3 periods a forced titration dose period of 2 weeks a flexible dose period of 50 weeks and a tapering dose period of 0-4 weeks After the last dose of study drug including tapering dose period or the early termination visit participants will be followed for up to 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None