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.
This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. 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. Subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The subject's participation in the study will be for approximately 42 days from day 0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
Normal saline solution
Clinical Research Solutions
Franklin, Tennessee, United States
Proportion of Patients With a ≥13 Point Improvement in FIQR Score
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
Time frame: Day 42
Change in BPI, Pain Interference
The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10.
Time frame: Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42
Change in FIQR Score
The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores.
Time frame: Change from Baseline in FIQR score at Day 42
Change in BPI, Pain Severity
The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10.
Time frame: Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42
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Change in Fatigue Visual Numeric Scale
Scores range from 0 to 10, with the higher score indicating more fatigue.
Time frame: Change from Baseline in Fatigue Visual Numeric Scale at Day 42
Change in Iron Indices, Serum Ferritin
Time frame: Change from Baseline in Iron Indices, Serum ferritin at Day 42
Change in Iron Indices - Transferrin Saturation
Time frame: Change from baseline in Iron Indices, Transferrin saturation, at Day 42