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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: Completed Phase 4 study, sponsored by Eisai.
NCT01127438 is a Phase 4 study that has completed, run by Eisai. The registered enrollment target is 153 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness.
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 |
What the finished NCT01127438 record still lists
NCT01127438 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which fospropofol disodium Subgroup 1 Lower Dose is the first listed.
NCT01127438 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01127438's enrollment target sits among peer trials
153 530th of 2000 higher than 1,471 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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