Study to Evaluate the Safety, Efficacy & Pharmacokinetics of Optimark

Clinical Trial Description

Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age). ;

Study Design

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04073290` - Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose	Phase 4
Recruiting	`NCT02681913` - Adenosine as an Adjunct to Blood Cardioplegia	Phase 2
Terminated	`NCT00527670` - Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT04073290 - Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Phase 4

Recruiting

NCT02681913 - Adenosine as an Adjunct to Blood Cardioplegia

Phase 2

Terminated

NCT00527670 - Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01092754
Study type	Interventional
Source	Guerbet
Contact
Status	Completed
Phase	Phase 4
Start date	May 2002
Completion date	December 2003

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms