Urinary Aquaporin 2 Excretion After NSAID in Fasting Heal... | NCT00281762

Studies
Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human

NCT00281762

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

May 9, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Healthy

Interventions

NSAID

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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

Not provided

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 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
NSAID	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

Not provided

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	Regional Hospital Holstebro	Study Chair
Thomas G Knudsen, MD	Regional Hospital Holstebro	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21029429	Derived	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.

Measure	Description	Time Frame
FeNa
U-AQP-2

Type	Date	Date Unknown
Release	Feb 27, 2010
Reset	Mar 18, 2010
Release	Aug 4, 2010
Reset	Aug 24, 2010
Release	Sep 19, 2010
Reset	Oct 6, 2010
Release	Jun 27, 2011
Reset	Jul 25, 2011
Release	Aug 3, 2011
Reset	Sep 1, 2011

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 27, 2010			Mar 18, 2010
Aug 4, 2010

ID	Term
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents