Phase
Condition
Hormone Deficiencies
Hyponatremia
Treatment
Placebo Infusion (blinded)
Mannitol Infusion (blinded)
Mannitol Infusion (open label)
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1: Proof of Concept in Healthy adults
Age ≥ 18 years
Healthy with no medication except hormonal contraception
Part 2: Pilot Study in Patients with primary polydipsia (PP) or arginine vasopressin deficiency (AVP-D)
Age ≥ 18 years
Evidence of polyuria > 40-50 ml/kg body weight per 24 hours and polydipsia > 3 Literper 24 hours or regular desmopressin medication corresponding to a diagnosis of PPor AVP-D
Exclusion
Exclusion Criteria:
Part 1: Proof of Concept in Healthy adults
Participation in a trial with investigational drugs within 30 days
Evidence of disordered drinking habits and diuresis defined as polyuria > 40-50ml/kg body weight per 24 hours and polydipsia > 3 Liter per 24 hours.
Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1,73 m2
Glucose > 11.1 mmol/L corresponding to the diagnosis of an uncontrolled diabetesmellitus
History of urinary tract obstruction
Problems with urination
Pregnancy or breastfeeding
Multiple allergies (≥ 3)
Evidence of acute illness
Part 2: Pilot Study in Patients with PP or AVP-D
Participation in a trial with investigational drugs within 30 days
Pregnancy or breastfeeding
Evidence of acute illness
eGFR < 60 ml/min/1,73 m2
Glucose > 11.1 mmol/L corresponding to the diagnosis of uncontrolled diabetesmellitus
History of urinary tract obstruction
Problems with urination
Therapy with diuretics
Multiple allergies (≥ 3)
Study Design
Study Description
Connect with a study center
University Hospital Basel
Basel, 4031
SwitzerlandActive - Recruiting
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