Trial Outcomes & Findings for Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia (NCT NCT02409459)
NCT ID: NCT02409459
Last Updated: 2018-02-20
Results Overview
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
COMPLETED
PHASE2
81 participants
Day 42
2018-02-20
Participant Flow
Participant milestones
| Measure |
Injectafer
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Group B: Placebo
|
Injectafer
n=41 Participants
Group A: Injectafer
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 10.85 • n=99 Participants
|
41 years
STANDARD_DEVIATION 11.07 • n=107 Participants
|
43 years
STANDARD_DEVIATION 10.97 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
History of iron intolerance
No
|
37 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
History of iron intolerance
Yes
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
History of drug allergy
No
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
History of drug allergy
Yes
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
IRLS score per Arm/Group
|
16.3 units on a scale
STANDARD_DEVIATION 14.9 • n=99 Participants
|
13.4 units on a scale
STANDARD_DEVIATION 13.16 • n=107 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 14.04 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: The Safety population consisted of all subjects who received at least one dose of randomized treatment. The Efficacy Evaluable Population consisted of all subjects who received at least 1 dose of randomized treatment with at least 1 completed post treatment FIQR evaluation.
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
Outcome measures
| Measure |
Injectafer
n=39 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=39 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Proportion of Patients With a ≥13 Point Improvement in FIQR Score
|
30 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
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.
Outcome measures
| Measure |
Injectafer
n=38 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=39 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in BPI, Pain Interference
|
-4.1 units on a scale
Standard Deviation 3.3
|
-2.3 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Change from Baseline in FIQR score at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
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.
Outcome measures
| Measure |
Injectafer
n=38 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=39 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in FIQR Score
|
-45.0 units on a scale
Standard Deviation 29.5
|
-29.7 units on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
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.
Outcome measures
| Measure |
Injectafer
n=38 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=39 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in BPI, Pain Severity
|
-3.1 units on a scale
Standard Deviation 2.7
|
-1.8 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Change from Baseline in Fatigue Visual Numeric Scale at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Scores range from 0 to 10, with the higher score indicating more fatigue.
Outcome measures
| Measure |
Injectafer
n=37 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=39 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in Fatigue Visual Numeric Scale
|
-3.7 units on a scale
Standard Deviation 3.2
|
-1.7 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Change from Baseline in Iron Indices, Serum ferritin at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Outcome measures
| Measure |
Injectafer
n=39 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=38 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in Iron Indices, Serum Ferritin
|
292.5 ug/L
Standard Deviation 145.9
|
2.0 ug/L
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Change from baseline in Iron Indices, Transferrin saturation, at Day 42Population: Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Outcome measures
| Measure |
Injectafer
n=39 Participants
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=38 Participants
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|---|---|---|
|
Change in Iron Indices - Transferrin Saturation
|
24.4 percent of transferrin saturation
Standard Deviation 11.4
|
5.8 percent of transferrin saturation
Standard Deviation 15.1
|
Adverse Events
Injectafer
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Injectafer
n=41 participants at risk
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Injectafer
|
Placebo
n=40 participants at risk
15 cc of Normal Saline IV push at 2 ml/minute
Placebo: Normal saline solution
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Number of events 3 • 7 months
|
0.00%
0/40 • 7 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/41 • 7 months
|
2.5%
1/40 • Number of events 1 • 7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/41 • 7 months
|
2.5%
1/40 • Number of events 1 • 7 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
1/41 • Number of events 1 • 7 months
|
0.00%
0/40 • 7 months
|
|
Vascular disorders
Flushing
|
14.6%
6/41 • Number of events 6 • 7 months
|
0.00%
0/40 • 7 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.4%
1/41 • Number of events 1 • 7 months
|
0.00%
0/40 • 7 months
|
|
Nervous system disorders
Dizziness
|
4.9%
2/41 • Number of events 2 • 7 months
|
0.00%
0/40 • 7 months
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/41 • Number of events 1 • 7 months
|
0.00%
0/40 • 7 months
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • 7 months
|
0.00%
0/40 • 7 months
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/41 • Number of events 1 • 7 months
|
0.00%
0/40 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place