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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01146197
First received: June 16, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Treatment-induced increased in plasma potassium concentration at the end of each two month treatment period [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (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®), 5-20 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®), 5-20 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®), 5-20 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®), 5-20 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®), 5-20 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®), 5-20 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®), 5-20 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146197

Contacts
Contact: Blanchard Anne, MD,PhD 01 56 09 29 13 ext 33 anne.blanchard@egp.aphp.fr
Contact: Andrieux Chantal, CEC 01 56 09 54 79 ext 33 chantal.andrieux@egp.aphp.fr

Locations
France
Hopital Européen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Anne Blanchard     01 56 09 29 13     anne.blanchard@egp.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Blanchard Anne, MD,PhD APHP
  More Information

No publications provided

Responsible Party: Valerie MILLUL, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT01146197     History of Changes
Other Study ID Numbers: P071242
Study First Received: June 16, 2010
Last Updated: June 16, 2010
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
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Amiloride
Sodium Channel Blockers
Diuretics
Indomethacin
Eplerenone
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Natriuretic Agents
Physiological Effects of Drugs
Gout Suppressants
Antirheumatic Agents
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013