NCT00281762

Brief Summary

We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of u-AQP-2 induced by fasting

Trial Health

80
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

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

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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

First QC Date

January 23, 2006

Last Update Submit

May 6, 2008

Conditions

Healthy

Keywords

AQP-2NSAIDUrinary concentrating ability

Outcome Measures

Primary Outcomes (2)

  • FeNa

  • U-AQP-2

Interventions

NSAIDDRUG

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

Related Publications (1)

  • Lauridsen TG, Vase H, Starklint J, Graffe CC, Bech JN, Nielsen S, Pedersen EB. Increased renal sodium absorption by inhibition of prostaglandin synthesis during fasting in healthy man. A possible role of the epithelial sodium channels. BMC Nephrol. 2010 Oct 28;11:28. doi: 10.1186/1471-2369-11-28.

    PMID: 21029429DERIVED

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Officials

  • Erling B Pedersen, Professor

    Regional Hospital Holstebro

    STUDY CHAIR

  • Thomas G Knudsen, MD

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

DK(1)