HealthyPhase 4NCT00281710
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
A Phase 4 study testing Methylprednisolone in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methylprednisolone
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2005to Feb 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Show all 11Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans
- Conditions
- Healthy
- Being tested
- Methylprednisolone
- Keywords
- AQP-2, Methylprednisolone, Urinary concentrating ability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
u-AQP-2
FeNa+
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Holstebro Hospital, 7500 Holstebro, DenmarkThomas G Knudsen, MD, Principal investigator, Holstebro Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281710
- Sponsor's protocol ID
- MED.RES.HOS.2005.02.TGK
- Status last verified
- May 2008
- First submitted
- 23 Jan 2006
- Last updated
- 9 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
- ClinicalTrials.gov ID
- NCT00281710
- Acronym / sponsor ID
- MED.RES.HOS.2005.02.TGK
- Conditions
- Healthy
- Keywords
- AQP-2, Methylprednisolone, Urinary concentrating ability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (11 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone | Drug | – |
Primary outcome
u-AQP-2
FeNa+
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B Pedersen, Professor study chair
Holstebro Hospital, 7500 Holstebro, Denmark
Thomas G Knudsen, MD principal investigator
Holstebro Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone in people with Healthy, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
u-AQP-2. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.