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

NCT04676139 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-19

No results posted yet for this study

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

DRUG

Fluoxetine

Fluoxetine 10 mg capsules once daily for 12 months

DRUG

Placebo

placebo for 12 months

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mahmoud Elkenawy · Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university

  • Tamer El-sayed Helmy · Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university

  • Ahmed Abdelhalem · Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university

  • Mohamed Hussiny abdelazim · Resident in Urology Urology and Nephrology canter Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676139 on ClinicalTrials.gov