Trial record 2 of 3 for:    "Gitelman syndrome"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01146197
First received: June 16, 2010
Last updated: December 9, 2013
Last verified: December 2009
  Purpose

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 Intervention Phase
Gitelman Syndrome
Drug: TREATMENT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the effectiveness of eplerenone and amiloride on hypokalemia. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 33
Study Start Date: February 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01146197     History of Changes
Other Study ID Numbers: P071242
Study First Received: June 16, 2010
Last Updated: December 9, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Gitelman Syndrome
Syndrome
Disease
Genetic Diseases, Inborn
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Pathologic Processes
Renal Tubular Transport, Inborn Errors
Urologic Diseases
Amiloride
Diuretics
Diuretics, Potassium Sparing
Eplerenone
Indomethacin
Sodium Channel Blockers
Acid Sensing Ion Channel Blockers
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Epithelial Sodium Channel Blockers
Gout Suppressants
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 29, 2014