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
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