NCT00281710

Brief Summary

We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Oct 2005

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

1.3 years

First QC Date

January 23, 2006

Last Update Submit

May 6, 2008

Conditions

Healthy

Keywords

AQP-2MethylprednisoloneUrinary concentrating ability

Outcome Measures

Primary Outcomes (2)

  • u-AQP-2

  • FeNa+

Interventions

MethylprednisoloneDRUG

Eligibility Criteria

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

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Holstebro Hospital

Holstebro, Denmark

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Erling B Pedersen, Professor

    Holstebro Hospital, 7500 Holstebro, Denmark

    STUDY CHAIR

  • Thomas G Knudsen, MD

    Holstebro Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

DK(1)