Liver CirrhosisPhase 1NCT00344916
Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Liver Cirrhosis, run by Regional Hospital Holstebro.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Ng-monomethyl-L-arginine (drug)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones
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.
Read the 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
- Conditions
- Liver Cirrhosis
- Being tested
- Ng-monomethyl-L-arginine (drug)
- Keywords
- Renal hemodynamics, Nitric oxide
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ng-monomethyl-L-arginine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, DenmarkJesper N Bech, MD, Ph.d., Principal investigator, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344916
- Sponsor's protocol ID
- MED.RES.HOS.1996.04.JNB
- Status last verified
- Jun 2006
- First submitted
- 24 Jun 2006
- Last updated
- 11 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones
- ClinicalTrials.gov ID
- NCT00344916
- Acronym / sponsor ID
- MED.RES.HOS.1996.04.JNB
- Conditions
- Liver Cirrhosis
- Keywords
- Renal hemodynamics, Nitric oxide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy controls
- Age 20 to 60 years
- Both men and women
- Weight below 100 kg
- Normal clinical examination and laboratory screening
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ng-monomethyl-L-arginine (drug) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B Pedersen, Professor study chair
Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Jesper N Bech, MD, Ph.d. principal investigator
Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with Liver Cirrhosis, run by Regional Hospital Holstebro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2006.