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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02538302
Other study ID # 92.121.505
Secondary ID
Status Completed
Phase Phase 3
First received August 27, 2015
Last updated August 29, 2015
Start date July 2013
Est. completion date August 2015

Study information

Verified date August 2015
Source Hormozgan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 14 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Minirin
Minirin 5 to 10 mg daily for 6 months
Oxybutynin
Oxybutynin 5 to 10 mg daily for 6 months

Locations

Country Name City State
Iran, Islamic Republic of Shahid Mohammadi hospital Bandar Abbas Hormozgan

Sponsors (1)

Lead Sponsor Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary ?Frequency of nocturnal enuresis Number of participants with nocturnal enuresis 6 months No
Secondary Frequency of urinary incontinency Number of participants with urinary incontinency 6 months No
Secondary Frequency of urgency Number of participants with urgency 6 months No
Secondary Frequency of Xerostomia Number of participants with Xerostomia 6 months Yes
Secondary Frequency of Xerophthalmia Number of participants with Xerophthalmia 6 months Yes
Secondary Frequency of Blurred vision Number of participants with Blurred vision 6 months Yes
Secondary Frequency of Dysphagia Number of participants with Dysphagia 6 months Yes
Secondary Frequency of constipation Number of participants with constipation 6 months Yes
Secondary Frequency of Diarrhea Number of participants with Diarrhea 6 months Yes
Secondary Frequency of Headache Number of participants with Headache 6 months Yes
Secondary Frequency of Seizure Number of participants with Seizure 6 months Yes
Secondary Frequency of Epistaxis Number of participants with Epistaxis 6 months Yes
Secondary Frequency of Abdominal pain Number of participants with Abdominal pain 6 months Yes
Secondary Frequency of Vomiting Number of participants with Vomiting 6 months Yes
Secondary Frequency of Ear ache Number of participants with Ear ache 6 months Yes
Secondary Frequency of Rhinitis Number of participants with Rhinitis 6 months Yes
Secondary Frequency of Chest pain Number of participants with Chest pain 6 months Yes
Secondary Frequency of Increase in appetite Number of participants with Increase in appetite 6 months Yes
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