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NCT02409459 · ClinicalTrials.gov registry record · Phase 2
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
A Phase 2 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT02409459: Completed Phase 2 study, sponsored by American Regent.
NCT02409459 is a Phase 2 study that has completed, run by American Regent. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02409459, a Phase 2 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. 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 42 days.
Primary Outcome
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
Interventions
- DRUG Placebo
- DRUG Injectafer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT02409459 record still lists
NCT02409459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02409459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02409459 about?
NCT02409459 is a clinical study titled "Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia". This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. 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 ...
What is the current status of trial NCT02409459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2015-03. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02409459?
The interventions under investigation include: Placebo (DRUG), Injectafer (DRUG).
Who is sponsoring clinical trial NCT02409459?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02409459's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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