Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis | NCT00344916

Studies
Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis

NCT00344916

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Jul 11, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Liver Cirrhosis

Interventions

Ng-monomethyl-L-arginine (drug)

Countries

Not provided

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

Jun 2006

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

Not provided

Completion Date

Not provided

First Submitted Date

Jun 24, 2006

First Submission Date that Met QC Criteria

Jun 24, 2006

First Posted Date

Jun 27, 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

Jul 10, 2006

Last Update Posted Date

Jul 11, 2006Estimated

Description Module

Brief Summary

Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

Detailed Description

In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:

renal hemodynamics (GFR and RPF)
blood pressure and heart rate
lithium clearance
plasma levels of vasoactive hormones

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ng-monomethyl-L-arginine (drug)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy controls

Age 20 to 60 years
Both men and women
Weight below 100 kg
Normal clinical examination and laboratory screening
Fertile women only if using contraception
Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
P-creatinine < 250 µmol/L
Age 20-60 years
Both men and women
Fertile women only if using contraception
Body weight below 100 kg
Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
Current medication
Drugs or alcohol abuse
Pregnancy
Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
Donation of blood less than 1 month before the experiments

Liver cirrhosis

Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
Drugs or alcohol abuse
Pregnancy
Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Erling B Pedersen, Professor	Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark	Study Chair
Jesper N Bech, MD, Ph.d.	Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark	Principal Investigator

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

ID	Term
D019323	omega-N-Methylarginine
D004364	Pharmaceutical Preparations

ID	Term
D001120	Arginine
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins