Study Stopped
This study was prematurely terminated (26 June 2009) due to slow recruitment
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placebo-controlled Study
1 other identifier
interventional
20
1 country
11
Brief Summary
This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2006
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2006
CompletedFirst Posted
Study publicly available on registry
July 17, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMarch 4, 2010
March 1, 2010
2.7 years
July 14, 2006
March 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score
10 weeks
Secondary Outcomes (1)
The Clinical Global Impression(CGI) improvement at Week 10
10 weeks
Study Arms (2)
F
EXPERIMENTALP
PLACEBO COMPARATORInterventions
Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
S114.3.118 Kohnodai Hospital, National Center of N
Chiba Prefecture, Japan
S114.3.118 Kyushu University Hospital
Fukuoka Prefecture, Japan
S114.3.118 Hiroshima-city Funairi Hospital
Hiroshima Prefecture, Japan
S114.3.118 Goryokai Hospital
Hokkaido Prefecture, Japan
S114.3.118 Hyogo Children's Hospital
Hyogo Prefecture, Japan
S114.3.118 Kobe University Hospital
Hyogo Prefecture, Japan
S114.3.118 National Hospital Organization Kagawa C
Kagawa Prefecture, Japan
S114.3.118 National Hospital Organization Kikuti N
Kumamoto Prefecture, Japan
S114.3.118 National Hospital Organization Sakakiba
Mie Prefecuture, Japan
S114.3.118 Nara Medical University Hospital
Nara Prefecture, Japan
S114.3.118 Tokushima University Hospital
Tokushima Prefecture, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshiaki Yamaguchi
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2006
First Posted
July 17, 2006
Study Start
August 1, 2006
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
March 4, 2010
Record last verified: 2010-03