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Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine

This study has been withdrawn prior to enrollment.
(no patients could be recruited)
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00298753
First received: March 1, 2006
Last updated: July 11, 2007
Last verified: September 2006
  Purpose

Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that these patients have a higher reabsorption of water during the Aquaporine2 water channels,a higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation will tend to normalize, when the patients are treated with fluid restriction


Condition Intervention Phase
Syndrome of Inappropriate ADH-Secretion
Procedure: fluid restriction for 14 days (15ml fluid per kg weight)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine

Further study details as provided by Regional Hospital Holstebro:

Estimated Enrollment: 30
Study Start Date: May 2005
Detailed Description:

The purpose of the study is to determine the amount of Aquaporine2(AQP2)in the urine in patients treated with the antiepileptic drug Oxcarbazepine before and after the administration of fluid restriction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age more than 18 years, both men and women, patients with epilepsia treated with Oxcarbazepine, and a Sodium content in plasma lower than 130 mmol/liter

Exclusion Criteria:

severe diseases in the heart, lungs or liver;diabetes mellitus, other not-well treated diseases in endocrine organs, cancer; unwillingness to participate

  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: NCT00298753

Locations
Denmark
Department of Medicine, Holstebro Hospital
Holstebro, Jutland, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B Pedersen, Professor Holstebro Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298753     History of Changes
Other Study ID Numbers: MED.RES.HOS.2005.04/IMT
Study First Received: March 1, 2006
Last Updated: July 11, 2007
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Inappropriate ADH Syndrome
Syndrome
Brain Diseases
Central Nervous System Diseases
Disease
Endocrine System Diseases
Hypothalamic Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Pituitary Diseases
Water-Electrolyte Imbalance
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014