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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

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.

Condition or disease Intervention/treatment Phase
Gitelman Syndrome Drug: TREATMENT Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
Study Start Date : February 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Amiloride, Indometacin, Eplerenone
Amiloride, indometacin(+Omeprazole), Eplerenone
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, Eplerenone, indometacin
Amiloride, Eplerenone, indometacin (+Omeprazole)
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: Eplerenone, Amiloride, indometacin
Eplerenone, Amiloride, indometacin (+Omeprazole)
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: Eplerenone, Indometacin, Amiloride
Eplerenone, Indometacin, Amiloride
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: Indometacin, Eplerenone, Amiloride
Indometacin, Eplerenone, Amiloride
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: Indometacin, Amiloride, Eplerenone
Indometacin, Amiloride, Eplerenone
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




Primary Outcome Measures :
  1. To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. [ Time Frame: 2 months ]
  3. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146197


Locations
France
Hopital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Blanchard Anne, MD,PhD APHP

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01146197     History of Changes
Other Study ID Numbers: P071242
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypokalemia
Hypomagnesemia
Salt loosing nephropathy

Additional relevant MeSH terms:
Syndrome
Gitelman Syndrome
Disease
Pathologic Processes
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diuretics
Eplerenone
Amiloride
Indomethacin
Sodium Channel Blockers
Diuretics, Potassium Sparing
Natriuretic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors