- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00281710
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
May 6, 2008 updated by: Regional Hospital Holstebro
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans
Study Overview
Study Type
Interventional
Enrollment
20
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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Holstebro, Denmark
- 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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) Genders; both mal and female
- (2) Age; 18- 65 years old
- (3) BMI; below 30
- (4) Females had to bee in oral contraceptive treatment
Exclusion Criteria:
- (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
- (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
- (3) Albuminuria or glucosuria
- (4) Cancer
- (5) Arterial hypertension
- (6) Alcohol abuse
- (7) Use of tobacco
- (8) Medical treatment, except oral contraceptives
- (9) Pregnancy or breast feeding
- (10) Medicine abuse
- (11) Donation of blood less than 1 month before the study.
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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u-AQP-2
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FeNa+
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Erling B Pedersen, Professor, Holstebro Hospital, 7500 Holstebro, Denmark
- Principal Investigator: Thomas G Knudsen, MD, Holstebro Sygehus
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
October 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
January 23, 2006
First Submitted That Met QC Criteria
January 23, 2006
First Posted (Estimate)
January 25, 2006
Study Record Updates
Last Update Posted (Estimate)
May 9, 2008
Last Update Submitted That Met QC Criteria
May 6, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- MED.RES.HOS.2005.02.TGK
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.