- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298753
Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine
September 14, 2015 updated by: Regional Hospital Holstebro
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jutland
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Holstebro, Jutland, Denmark, 7500
- Department of Medicine, Holstebro Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Registration Dates
First Submitted
March 1, 2006
First Submitted That Met QC Criteria
March 1, 2006
First Posted (ESTIMATE)
March 3, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 14, 2015
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED.RES.HOS.2005.04/IMT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Syndrome of Inappropriate ADH-secretion
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Otsuka Pharmaceutical Europe LtdCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionSpain
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Otsuka Pharmaceutical Europe LtdCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionGermany, Spain
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Otsuka Pharmaceutical Europe LtdCompletedCancer | Hyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionItaly
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University of Erlangen-Nürnberg Medical SchoolCompletedHyponatremia | Pituitary | Syndrome of Inappropriate ADH (SIADH) Secretion
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SanofiCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionFrance, Germany, Belgium, Hungary
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Otsuka Pharmaceutical Co., Ltd.CompletedSyndrome of Inappropriate Antidiuretic Hormone SecretionJapan
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Otsuka Pharmaceutical Development & Commercialization...CompletedSyndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)Germany, United Kingdom, Spain, Sweden, Hungary, Czech Republic, Denmark
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University Hospital, Basel, SwitzerlandCompletedSyndrome of Inappropriate Antidiuresis (SIAD)Switzerland
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European Georges Pompidou HospitalCompletedHyponatremia | SIAD - Syndrome of Inappropriate AntidiuresisFrance
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Seattle Children's HospitalAmerican Academy of PediatricsCompletedFluid and Electrolyte Imbalance | Intravenous Fluids | ADH InappropriateUnited States
Clinical Trials on fluid restriction for 14 days (15ml fluid per kg weight)
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Swiss Federal Institute of TechnologyCompletedAnemia | Iron Deficiency Anemia | Iron DeficiencySwitzerland