NCT00806468
Terminated
Phase 4
A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Johannes Gutenberg University Mainz1 site in 1 country1 target enrollmentFebruary 2009
Overview
- Phase
- Phase 4
- Intervention
- Desmotabs
- Conditions
- Parkinson Disease
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- average nocturnal micturition frequency within the 2 weeks treatment phase each
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
Brief Summary
This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male patients with idiopathic Parkinson Syndrome
- •18 to 85 years
- •Nocturnal Pollakisuria \> 2 mictions /night (documented in Screening phase )
- •Na+ i.S \> 135 mmol/l
- •Patient is able to understand all aspects and individual consequences of the clinical trial
- •An informed consent signed and dated by the patient is available prior to any study specific treatment
- •The study is consistent with the patients´ request for an appropriate treatment
Exclusion Criteria
- •Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
- •Central Diabetes insipidus
- •Known heart insufficiency (NYHA Stad. III und IV)
- •clinical relevant kidney insufficiency
- •Habitual and psychogenic Polydipsia
- •Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
- •Participation in another clinical trial during or within 6 months prior to this clinical trial
- •Medical or psychological condition, which might endanger the proper conduction of the clinical trial
- •Known drug or alcohol abuse
Arms & Interventions
Desmopressin
Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.
Intervention: Desmotabs
Outcomes
Primary Outcomes
average nocturnal micturition frequency within the 2 weeks treatment phase each
Time Frame: 6 weeks
Secondary Outcomes
- safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome(8 weeks)
Study Sites (1)
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