E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
lithium-induced urinary concentrating defects (nephrogenic diabetes insipidus) |
|
E.1.1.1 | Medical condition in easily understood language |
excessive urine production due to a diminished urinary concentrating ability of the kidneys |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050501 |
E.1.2 | Term | Lithium toxicity |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012600 |
E.1.2 | Term | Diabetes insipidus nephrogenic |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to explore the prevalence of urinary concentrating defects in a Dutch population of lithium treated patients |
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E.2.2 | Secondary objectives of the trial |
to determine the relation of the dDAVP test results with complaints (micturition history) and clinical parameters (duration of lithium therapy, plasma lithium concentration, baseline plasma creatinine, sodium and potassium concentration and baseline urinary osmolality) of lithium treated patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
stable patients with a mood disorder treated with lithium
men and women
age ≥ 18 years |
|
E.4 | Principal exclusion criteria |
general contra-indications for participation in a trial:
o inability to give informed consent
o pregnancy
o unstable psychiatric condition
alternative causes of (nephrogenic) diabetes insipidus:
o hypo/hyperkalemia (plasma potassium < 3.5 or > 5.5 mmol/l)
o severe hypercalcemia (albumin-corrected plasma calcium > 2.80 mmol/l)
o hyperglycemia (plasma glucose > 10.0 mmol/l)
o history of amyloidosis, Sjögren’s syndrome or Sickle cell anemia
o previous treatment with ifosfamide
o established primary polydipsia or central diabetes insipidus
contra-indications for dDAVP administration:
o inability to comply with water restriction
o renal insufficiency (GFR < 45 ml/min/1.73 m2)
o hyponatremia (plasma sodium < 130 mmol/l
other:
o concomitant treatment with desmopressin or democlocycline |
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E.5 End points |
E.5.1 | Primary end point(s) |
maximal renal concentrating ability determined by measuring urine osmolality after intranasal administration of dDAVP 40 micrograms |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after intranasal administration of dDAVP 40 micrograms, urine will be collected by voluntary voiding for measuring urine osmolality every 60-120 minutes for a total duration of 6 hours |
|
E.5.2 | Secondary end point(s) |
the relation of the dDAVP test results with complaints (micturition history) and clinical parameters (duration of lithium therapy, plasma lithium concentration, baseline plasma creatinine, sodium and potassium concentration and baseline urinary osmolality) of lithium treated patients |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |