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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146197

Acronym

GITAB

Enrollment

Registered

2010-06-17

Start date

2010-02-28

Completion date

2013-01-31

Last updated

2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gitelman Syndrome

Keywords

Hypokalemia, Hypomagnesemia, Salt loosing nephropathy

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.

Interventions

DRUGTREATMENT

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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026