At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 81 enrolled
Drug / intervention
Injectafer +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia
In Brief
A Phase 2 clinical trial evaluating Injectafer and Placebo for Iron Deficiency and Fibromyalgia. Completed, enrolled 81 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency, Fibromyalgia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedApr 2015
Primary CompletionOct 2015
Study CompletionMar 2016
TodayJul 2026
First PostedApr 6, 2015
Enrollment StartMar 1, 2015
Primary CompletionOct 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.2 years ago
Interventions
Injectaferdrug
Placebodrug
Normal saline solution