Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT02636387|
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nocturnal Enuresis Anemia, Sickle Cell||Drug: Desmopressin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Desmopressin as a Therapy for Nocturnal Enuresis in Patients With Sickle Cell Disease|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Placebo Comparator: Placebo
0.2 mg tablets, dose titrated to effect
Sugar pill manufactured to mimic 0.2 pill of desmopressin. Take two pills at bedtime, if no improvement in 14 days then will take 3 pills at bedtime for an additional 14 days
0.2mg tablets, dose titrated to effect after
Two desmopressin 0.2 mg tablets at bedtime for 14 days and if <50 % improvement then increase to three 0.2 mg tablets at bedtime for 14 days
- Reduction in Bedwetting episodes [ Time Frame: Baseline and 4 weeks ]The investigators primary endpoint is to detect a 50 % difference between placebo and desmopressin treatment groups in number of wet nights after treatment implementation. This will be assessed by patient study diary.
- Quality of life measure [ Time Frame: Baseline and 4 weeks ]To determine if patients with sickle cell disease and nocturnal enuresis receiving desmopressin will have an improved quality of life compared to the control group. The investigators will assess quality of life by administering the Promis Fatigue Scale prior to administering the study drug and 4 weeks after the intervention.
- Reduction in Nighttime awakenings [ Time Frame: Baseline and 4 weeks ]To determine if the use of desmopressin in patients with nocturnal enuresis improves rates of nocturia, defined as episodes of nighttime awakening to void, compared to placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636387
|Contact: Kerry A Morrone, MDfirstname.lastname@example.org|
|Contact: Deepa Manwani, MDemail@example.com|
|Principal Investigator:||Kerry A Morrone, MD||Children's Hospital at Montefiore|