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NCT02826681 · ClinicalTrials.gov registry record · Phase 2
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
A Phase 2 study, sponsored by American Regent.
- Terminated
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT02826681 is a Phase 2 study that was terminated before completion, run by American Regent. The registered enrollment target is 70 participants.
The verdict
NCT02826681, a Phase 2 study, was terminated before completion, sponsored by American Regent.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA). Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior FCM treatment and to determine the effectiveness of further iron repletion with FCM when RLS symptoms worsen or reoccur.
Interventions
- DRUG Placebo (Normal Saline)
- DRUG Injectafer® (Ferric Carboxymaltose - FCM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02826681
The ClinicalTrials.gov registry entry for NCT02826681 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 70 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 (Normal Saline) is the first listed.
NCT02826681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02826681 about?
NCT02826681 is a clinical study titled "Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia". Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA). Long-Term Extension Phase III Primary Objective: To evaluate the duration of effect of prior FCM trea...
What is the current status of trial NCT02826681?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2017-07-10. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT02826681?
The interventions under investigation include: Placebo (Normal Saline) (DRUG), Injectafer® (Ferric Carboxymaltose - FCM) (DRUG).
Who is sponsoring clinical trial NCT02826681?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
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