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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
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Iron Deficiency
Fibromyalgia
Interventions Drug: Injectafer
Drug: Placebo
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Period Title: Overall Study
Started 41 40
Completed 40 39
Not Completed 1 1
Arm/Group Title Placebo Injectafer Total
Hide Arm/Group Description Group B: Placebo Group A: Injectafer Total of all reporting groups
Overall Number of Baseline Participants 40 41 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 81 participants
44  (10.85) 41  (11.07) 43  (10.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
Female
40
 100.0%
40
  97.6%
80
  98.8%
Male
0
   0.0%
1
   2.4%
1
   1.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 40 participants 41 participants 81 participants
African American
7
  17.5%
7
  17.1%
14
  17.3%
Asian
0
   0.0%
1
   2.4%
1
   1.2%
Caucasian
30
  75.0%
33
  80.5%
63
  77.8%
Hispanic
2
   5.0%
0
   0.0%
2
   2.5%
Other
1
   2.5%
0
   0.0%
1
   1.2%
History of iron intolerance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
No
37
  92.5%
35
  85.4%
72
  88.9%
Yes
3
   7.5%
6
  14.6%
9
  11.1%
History of drug allergy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 81 participants
No
17
  42.5%
21
  51.2%
38
  46.9%
Yes
23
  57.5%
20
  48.8%
43
  53.1%
IRLS score per Arm/Group   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 40 participants 41 participants 81 participants
16.3  (14.9) 13.4  (13.16) 14.8  (14.04)
[1]
Measure Description:

'International Restless Legs Syndrome Study Group Rating Scale' (IRLS) The IRLS is composed of 10 items. It gives a global score for all 10 items that is most commonly used as an overall severity score. 9 of the 10 items investigate two dimensions of the RLS severity. Item 3 is part of the diagnostic criteria and does not belong to any of the two dimensions. It is used for the total score for overall RLS severity.

Symptom severity subscale: 0-24 Impact on daily living subscale: 0-12 Global score: 0-40 For all scores, higher score = higher symptom impact.

1.Primary Outcome
Title Proportion of Patients With a ≥13 Point Improvement in FIQR Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
30
  76.9%
26
  66.7%
2.Secondary Outcome
Title Change in BPI, Pain Interference
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.1  (3.3) -2.3  (2.6)
3.Secondary Outcome
Title Change in FIQR Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-45.0  (29.5) -29.7  (27.0)
4.Secondary Outcome
Title Change in BPI, Pain Severity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.1  (2.7) -1.8  (2.1)
5.Secondary Outcome
Title Change in Fatigue Visual Numeric Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (3.2) -1.7  (2.2)
6.Secondary Outcome
Title Change in Iron Indices, Serum Ferritin
Hide Description [Not Specified]
Time Frame Change from Baseline in Iron Indices, Serum ferritin at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: ug/L
292.5  (145.9) 2.0  (13.8)
7.Secondary Outcome
Title Change in Iron Indices - Transferrin Saturation
Hide Description [Not Specified]
Time Frame Change from baseline in Iron Indices, Transferrin saturation, at Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Patients without a particular measure at a required time point were excluded from the analysis of that measure.
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description:

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Normal Saline

Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: percent of transferrin saturation
24.4  (11.4) 5.8  (15.1)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Injectafer Placebo
Hide Arm/Group Description

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Injectafer

15 cc of Normal Saline IV push at 2 ml/minute

Placebo: Normal saline solution

All-Cause Mortality
Injectafer Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Injectafer Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Injectafer Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/41 (39.02%)      2/40 (5.00%)    
Ear and labyrinth disorders     
Ear discomfort  1  1/41 (2.44%)  1 0/40 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  3/41 (7.32%)  3 0/40 (0.00%)  0
Infections and infestations     
Oral herpes  1  0/41 (0.00%)  0 1/40 (2.50%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/41 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders     
Dizziness  1  2/41 (4.88%)  2 0/40 (0.00%)  0
Dysgeusia  1  1/41 (2.44%)  1 0/40 (0.00%)  0
Headache  1  1/41 (2.44%)  1 0/40 (0.00%)  0
Paraesthesia  1  1/41 (2.44%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/41 (2.44%)  1 0/40 (0.00%)  0
Vascular disorders     
Flushing  1  6/41 (14.63%)  6 0/40 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark A. Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610.650.4200 ext 844
EMail: mfalone@luitpold.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT02409459    
Other Study ID Numbers: 1VIT14038
First Submitted: April 1, 2015
First Posted: April 6, 2015
Results First Submitted: April 18, 2017
Results First Posted: December 13, 2017
Last Update Posted: February 20, 2018