Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02397057 · ClinicalTrials.gov registry record · Phase 3
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
A Phase 3 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 209
- Enrollment target
NCT02397057 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 209 participants.
The verdict
NCT02397057, a Phase 3 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 209 participants
- Enrollment target
Study Summary
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation in the study will be for approximately 1 year from Day 0.
Interventions
- OTHER Placebo
- DRUG Injectafer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02397057
The ClinicalTrials.gov registry entry for NCT02397057 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02397057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02397057 about?
NCT02397057 is a clinical study titled "Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS". This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 12 months. The subject's participation...
What is the current status of trial NCT02397057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 209 participants. The study started on 2015-01. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02397057?
The interventions under investigation include: Placebo (OTHER), Injectafer (DRUG).
Who is sponsoring clinical trial NCT02397057?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.