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NCT02633501 · ClinicalTrials.gov registry record · Phase 2
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
A Phase 2 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
NCT02633501 is a Phase 2 study that has completed, run by Guerbet. The registered enrollment target is 312 participants.
The verdict
NCT02633501, a Phase 2 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
Study Summary
The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
Interventions
- DEVICE MRI
- DRUG Gadobenate dimeglumine
- DRUG P03277
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02633501
The ClinicalTrials.gov registry entry for NCT02633501 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guerbet, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MRI is the first listed.
NCT02633501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02633501 about?
NCT02633501 is a clinical study titled "P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)". The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-know...
What is the current status of trial NCT02633501?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2016-06. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02633501?
The interventions under investigation include: MRI (DEVICE), Gadobenate dimeglumine (DRUG), P03277 (DRUG).
Who is sponsoring clinical trial NCT02633501?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
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