Minirin Versus Oxybutynin for Nocturnal Enuresis in Children

NCT ID: NCT02538302

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

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Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Detailed Description

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Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.

Conditions

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Nocturnal Enuresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Minirin

120 microgram per day for 2 months, then 60 microgram per day for 2 months, then 60 microgram every two days for two months

Group Type EXPERIMENTAL

Minirin

Intervention Type DRUG

Minirin 5 to 10 mg daily for 6 months

Oxybutynin

5 mg Oxybutynin twice a daily for 6 months

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type DRUG

Oxybutynin 5 to 10 mg daily for 6 months

Interventions

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Minirin

Minirin 5 to 10 mg daily for 6 months

Intervention Type DRUG

Oxybutynin

Oxybutynin 5 to 10 mg daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Desmopressin acetate Ditropan

Eligibility Criteria

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Inclusion Criteria

* \>5 years old
* Nocturnal enuresis
* Candidate for pharmacological treatment

Exclusion Criteria

* Children who their parents did noted filled the informed consent form
* Impossibility of follow up during the study period
* History of seizure
* History of rheumatologic disorders such as sjogren's disease
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamidreza Mahboobi, M.D

Role: PRINCIPAL_INVESTIGATOR

Hormozgan University of Medical Sciences

Locations

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Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

References

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Ghasemi K, Esteghamati M, Mohammadzadeh M, Zare S. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial. Electron Physician. 2016 Mar 25;8(3):2187-93. doi: 10.19082/2187. eCollection 2016 Mar.

Reference Type DERIVED
PMID: 27123229 (View on PubMed)

Other Identifiers

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92.121.505

Identifier Type: -

Identifier Source: org_study_id

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