NCT00298753

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2006

First QC Date

March 1, 2006

Last Update Submit

September 14, 2015

Conditions

Syndrome of Inappropriate ADH-secretion

Interventions

fluid restriction for 14 days (15ml fluid per kg weight)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Holstebro Hospital

Holstebro, Jutland, 7500, Denmark

Location

Study Officials

  • Erling B Pedersen, Professor

    Holstebro Hospital, Denmark

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

May 1, 2005

Last Updated

September 15, 2015

Record last verified: 2006-09

Locations

DK(1)