Official Title: “Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine”

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

Study Type: Interventional

Study Design: Non-Randomized, Open Label, Placebo Control, Parallel Assignment

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

Intervention(s) in this Clinical Trial

• Procedure: fluid restriction for 14 days (15ml fluid per kg weight)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Holstebro Hospital

Overall Clinical Trial Officials and Contacts

Erling B Pedersen, Professor Study Chair Holstebro Hospital, Denmark  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00298753

Study ID Number: MED.RES.HOS.2005.04/IMT

ClinicalTrials.gov Identifier: NCT00298753

Health Authority: Denmark: Ethics Committee