Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|