Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders.

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2012-004071-39-IT
• Date of registration: 31/10/2012
• Prospective Registration: No
• Primary sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
• Public title: Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders.
• Scientific title: Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.
• Date of first enrolment: 16/10/2012
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004071-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Fluid restriction Number of treatment arms in the trial: 2

Countries of recruitment

Italy

Contacts

• Name: U.O. ENDOCRINOLOGIA
• Affiliation: FONDAZIONE IRCCS CA'GRANDA OSPEDALE MAGGIORE POLICLINICO

• Name: U.O. ENDOCRINOLOGIA
• Affiliation: FONDAZIONE IRCCS CA'GRANDA OSPEDALE MAGGIORE POLICLINICO

Key inclusion & exclusion criteria

Inclusion criteria:
- age >18
- admission to Neurosurgery Unit for pituitary surgery
- Serum sodium levels lower than 135 mEq/l and higher than 120 mEq/l
- One or more symptoms of hyponatremia
- Euvolemic patient
- Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
- Anuria
- Impaired renal function(grade IV KDOQI)
- Liver failure
- Hypovolemia
- Hyponatremic hypovolemia
- Lack of sense to thirst
- Cotreatment with inhibitors/inductors of CYP3A4
- Pregnancy
- Brestfeeding


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: SAMSCA*10CPR 15MG
Pharmaceutical Form: Tablet
INN or Proposed INN: TOLVAPTAN
CAS Number: 150683-30-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-

Primary Outcome(s)

Main Objective: Evaluation of effectiveness and safety of Tolvaptan in the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.

Primary end point(s): Normalization of serum sodium levels in patients affected by sindrome of inappropriate secretion of antidiuretic hormone

Secondary Objective: Evaluation of mean resolution time of hyponatremia in the two groups of treatment (tolvaptan vs fluid resctriction).

Timepoint(s) of evaluation of this end point: Between 1 and 10 days

Secondary Outcome(s)

Secondary end point(s): Reduction of mean resolution time of hyponatremia in patients reated with Tolvaptan in respect to patients treated with fluid restriction

Timepoint(s) of evaluation of this end point: Between 1 and 10 days

Secondary ID(s)

TOLV2012

Source(s) of Monetary Support

FONDAZIONE IRCCS CA'GRANDA OSPEDALE MAGGIORE POLICLINICO