Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
|ClinicalTrials.gov Identifier: NCT02409459|
Recruitment Status : Completed
First Posted : April 6, 2015
Results First Posted : December 13, 2017
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Fibromyalgia||Drug: Injectafer Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||March 2016|
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Other Name: Ferric Carboxymaltose (FCM)
Placebo Comparator: Placebo
15 cc of Normal Saline IV push at 2 ml/minute
Normal saline solution
Other Name: Saline solution
- Proportion of Patients With a ≥13 Point Improvement in FIQR Score [ Time Frame: Day 42 ]The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
- Change in BPI, Pain Interference [ Time Frame: Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42 ]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.
- Change in FIQR Score [ Time Frame: Change from Baseline in FIQR score at Day 42 ]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.
- Change in BPI, Pain Severity [ Time Frame: Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42 ]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.
- Change in Fatigue Visual Numeric Scale [ Time Frame: Change from Baseline in Fatigue Visual Numeric Scale at Day 42 ]Scores range from 0 to 10, with the higher score indicating more fatigue.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409459
|United States, Tennessee|
|Clinical Research Solutions|
|Franklin, Tennessee, United States, 37064|
|Study Director:||Mark A Falone, MD||American Regent, Inc.|