CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
Fluvoxamine maleate +1 moredrug
Likely dose
Fluvoxamine maleate 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01933919
NCT01933919Phase 3Completed
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A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder

AbbVie·interventional·Posted Sep 2, 2013·Updated Dec 4, 2017

In Brief

A Phase 3 clinical trial evaluating Fluvoxamine maleate and Placebo for Obsessive Compulsive Disorder. Completed, enrolled 38 participants.

Detailed 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 Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent 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 pediatric/adolescent patients with OCD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObsessive Compulsive Disorder
Countries--
CollaboratorsMeiji Seika Pharma Co., Ltd.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2, 2013
Enrollment StartAug 14, 2013
Primary CompletionJun 18, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

Fluvoxamine maleatedrug

Film-coated tablet containing 25 mg of fluvoxamine maleate

Placebodrug

Placebo tablet matching to fluvoxamine maleate