Urinary Aquaporin 2 Excretion After Methylprednisolone in... | NCT00281710

Studies
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

NCT00281710

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 9, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Healthy

Interventions

Methylprednisolone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jan 23, 2006

First Submission Date that Met QC Criteria

Jan 23, 2006

First Posted Date

Jan 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2008

Last Update Posted Date

May 9, 2008Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Methylprednisolone	Drug

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, Professor	Holstebro Hospital, 7500 Holstebro, Denmark	Study Chair
Thomas G Knudsen, MD	Holstebro Sygehus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Holstebro Hospital		Holstebro			Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
u-AQP-2
FeNa+