Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics (GITAB)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gitelman Syndrome

Treatments: Drug: TREATMENT

Study type: Interventional

Funder types: Other

Identifiers

NCT01146197

P071242

Details and patient eligibility

About

Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

Full description

Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.

Exclusion criteria

• counter-indication to treatment under study
• Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 6 patient groups

Amiloride, Indometacin, Eplerenone

Experimental group

Description:

Amiloride, indometacin(+Omeprazole), Eplerenone

Treatment:

Drug: TREATMENT

Amiloride, Eplerenone, indometacin

Experimental group

Description:

Amiloride, Eplerenone, indometacin (+Omeprazole)

Treatment:

Drug: TREATMENT

Eplerenone, Amiloride, indometacin

Experimental group

Description:

Eplerenone, Amiloride, indometacin (+Omeprazole)

Treatment:

Drug: TREATMENT

Eplerenone, Indometacin, Amiloride

Experimental group

Description:

Eplerenone, Indometacin, Amiloride

Treatment:

Drug: TREATMENT

Indometacin, Eplerenone, Amiloride

Experimental group

Description:

Indometacin, Eplerenone, Amiloride

Treatment:

Drug: TREATMENT

Indometacin, Amiloride, Eplerenone

Experimental group

Description:

Indometacin, Amiloride, Eplerenone

Treatment:

Drug: TREATMENT