MedDataX Logo

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

NCT ID: NCT01146197

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gitelman Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hypokalemia Hypomagnesemia Salt loosing nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amiloride, Indometacin, Eplerenone

Amiloride, indometacin(+Omeprazole), Eplerenone

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Amiloride, Eplerenone, indometacin

Amiloride, Eplerenone, indometacin (+Omeprazole)

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Eplerenone, Amiloride, indometacin

Eplerenone, Amiloride, indometacin (+Omeprazole)

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Eplerenone, Indometacin, Amiloride

Eplerenone, Indometacin, Amiloride

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Indometacin, Eplerenone, Amiloride

Indometacin, Eplerenone, Amiloride

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Indometacin, Amiloride, Eplerenone

Indometacin, Amiloride, Eplerenone

Group Type EXPERIMENTAL

TREATMENT

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MODAMINE; Inspra and CHRONOINDOCID

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Blanchard Anne, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Européen Georges Pompidou

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

Reference Type DERIVED
PMID: 33107592 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P071242

Identifier Type: -

Identifier Source: org_study_id