NCT04676139

The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.

Conditions

• Nocturnal Enuresis

Interventions

Type	Name	Description
DRUG	Fluoxetine	Fluoxetine 10 mg capsules once daily for 12 months
DRUG	Placebo	placebo for 12 months

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2020-12-19
• Last updated: 2020-12-19

Locations

1 site across 1 country: Egypt