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

Gitelman Syndrome Clinical Trial

— GITAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146197
• Other study ID #: P071242
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 16, 2010
• Last updated: December 9, 2013
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gitelman Syndrome
• Syndrome

Intervention

Drug:
• TREATMENT
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.

Locations

Country	Name	City	State
France	Hopital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone		2 months	Yes
Secondary	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	Yes
Secondary	To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.		2 months	Yes
Secondary	To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders	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.	2 months	Yes