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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

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date December 10, 2013
Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
Treatment-induced increased in plasma potassium concentration at the end of each two month treatment period [ Time Frame: 2 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
Official Title  ICMJE Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gitelman Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
50
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146197
Other Study ID Numbers  ICMJE P071242
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Blanchard Anne, MD,PhD APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2009

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