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

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gitelman Syndrome

Intervention: TREATMENT (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Blanchard Anne, MD,PhD, Principal Investigator, Affiliation: APHP

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.

Clinical Details

Official title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone

Secondary outcome:

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)

To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.

To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hopital Européen Georges Pompidou, Paris 75015, France
Additional Information

Starting date: February 2010
Last updated: December 9, 2013

Page last updated: August 23, 2015

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