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

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ClinicalTrials.gov Identifier: NCT01146197
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

June 16, 2010
June 17, 2010
December 10, 2013
February 2010
December 2012   (Final data collection date for primary outcome measure)
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [ Time Frame: 2 months ]
Treatment-induced increased in plasma potassium concentration at the end of each two month treatment period [ Time Frame: 2 months ]
Complete list of historical versions of study NCT01146197 on ClinicalTrials.gov Archive Site
  • 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) [ Time Frame: 2 months ]
  • To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. [ Time Frame: 2 months ]
  • To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders [ Time Frame: 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.
Treatment-induced increased in plasma magnesium concentration at the end of each two month treatment period, EKG modifications, quality of life improvement [ Time Frame: 2 months ]
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gitelman Syndrome
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.
Other Name: MODAMINE; Inspra and CHRONOINDOCID
  • Experimental: Amiloride, Indometacin, Eplerenone
    Amiloride, indometacin(+Omeprazole), Eplerenone
    Intervention: Drug: TREATMENT
  • Experimental: Amiloride, Eplerenone, indometacin
    Amiloride, Eplerenone, indometacin (+Omeprazole)
    Intervention: Drug: TREATMENT
  • Experimental: Eplerenone, Amiloride, indometacin
    Eplerenone, Amiloride, indometacin (+Omeprazole)
    Intervention: Drug: TREATMENT
  • Experimental: Eplerenone, Indometacin, Amiloride
    Eplerenone, Indometacin, Amiloride
    Intervention: Drug: TREATMENT
  • Experimental: Indometacin, Eplerenone, Amiloride
    Indometacin, Eplerenone, Amiloride
    Intervention: Drug: TREATMENT
  • Experimental: Indometacin, Amiloride, Eplerenone
    Indometacin, Amiloride, Eplerenone
    Intervention: Drug: TREATMENT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
50
January 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01146197
P071242
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Blanchard Anne, MD,PhD APHP
Assistance Publique - Hôpitaux de Paris
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP