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NCT01127438 · ClinicalTrials.gov registry record · Phase 4
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
A Phase 4 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 4
- Development phase
- 153
- Enrollment target
NCT01127438 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 153 participants.
The verdict
NCT01127438, a Phase 4 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 153 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
Interventions
- DRUG fospropofol disodium Subgroup 1 Lower Dose
- DRUG fospropofol disodium Subgroup 1 Approved Dose
- DRUG fospropofol disodium Subgroup 2 Lower Dose
- DRUG fospropofol disodium Subgroup 2 Approved Dose
- DRUG fospropofol disodium Subgroup 3 Lower Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01127438
The ClinicalTrials.gov registry entry for NCT01127438 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fospropofol disodium Subgroup 1 Lower Dose is the first listed.
NCT01127438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01127438 about?
NCT01127438 is a clinical study titled "A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations". The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
What is the current status of trial NCT01127438?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 153 participants. The study started on 2010-04. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01127438?
The interventions under investigation include: fospropofol disodium Subgroup 1 Lower Dose (DRUG), fospropofol disodium Subgroup 1 Approved Dose (DRUG), fospropofol disodium Subgroup 2 Lower Dose (DRUG), fospropofol disodium Subgroup 2 Approved Dose (DRUG), fospropofol disodium Subgroup 3 Lower Dose (DRUG).
Who is sponsoring clinical trial NCT01127438?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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