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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01146197
Collaborator
(none)
33
Enrollment
1
Location
6
Arms
35
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Feb 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • MODAMINE; Inspra and CHRONOINDOCID

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [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) [2 months]

    2. To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. [2 months]

    3. 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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Européen Georges Pompidou Paris France 75015

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Blanchard Anne, MD,PhD, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT01146197
    Other Study ID Numbers:
    • P071242
    First Posted:
    Jun 17, 2010
    Last Update Posted:
    Dec 10, 2013
    Last Verified:
    Dec 1, 2009
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Hypokalemia
    Hypomagnesemia
    Salt loosing nephropathy
    Additional relevant MeSH terms:
    Gitelman Syndrome
    Syndrome

    Study Results

    No Results Posted as of Dec 10, 2013