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

Phase 1

Completed

• Conditions: Gitelman Syndrome
• Interventions: Drug: TREATMENT

• Registration Number: NCT01146197
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-02
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amiloride, Indometacin, Eplerenone	TREATMENT	Amiloride, indometacin(+Omeprazole), Eplerenone
Amiloride, Eplerenone, indometacin	TREATMENT	Amiloride, Eplerenone, indometacin (+Omeprazole)
Indometacin, Amiloride, Eplerenone	TREATMENT	Indometacin, Amiloride, Eplerenone
Eplerenone, Amiloride, indometacin	TREATMENT	Eplerenone, Amiloride, indometacin (+Omeprazole)
Eplerenone, Indometacin, Amiloride	TREATMENT	Eplerenone, Indometacin, Amiloride
Indometacin, Eplerenone, Amiloride	TREATMENT	Indometacin, Eplerenone, Amiloride

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone	2 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio)	2 months
To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.	2 months
To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders	2 months	To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders other than hypokalemia (hypomagnesemia, hyperaldosteronism), glomerular filtration rate, hypotension, clinical tolerance, and quality of life.

Trial Locations

Locations (1)

Hopital Européen Georges Pompidou; 🇫🇷 Paris, France