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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectafer | Experimental | 15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute |
|
| Placebo | Placebo Comparator | 15 cc of Normal Saline IV push at 2 ml/minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectafer | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Falone, MD | American Regent, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Solutions | Franklin | Tennessee | 37064 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29149437 | Derived | Boomershine CS, Koch TA, Morris D. A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia. Rheumatol Ther. 2018 Jun;5(1):271-281. doi: 10.1007/s40744-017-0088-9. Epub 2017 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injectafer | 15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute Injectafer |
| FG001 | Placebo | 15 cc of Normal Saline IV push at 2 ml/minute Normal Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Group B: Placebo |
| BG001 | Injectafer | Group A: Injectafer |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Day 42 |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injectafer | 15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute Injectafer |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610.650.4200 | 844 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
Normal saline solution |
|
|
| 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. | 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. | Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42 |
| Change in Fatigue Visual Numeric Scale | Scores range from 0 to 10, with the higher score indicating more fatigue. | Change from Baseline in Fatigue Visual Numeric Scale at Day 42 |
| Change in Iron Indices, Serum Ferritin | Change from Baseline in Iron Indices, Serum ferritin at Day 42 |
| Change in Iron Indices - Transferrin Saturation | Change from baseline in Iron Indices, Transferrin saturation, at Day 42 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| History of iron intolerance | Count of Participants | Participants |
|
| History of drug allergy | Count of Participants | Participants |
|
| IRLS score per Arm/Group | '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. | Mean | Standard Deviation | units on a scale |
|
15 cc of Normal Saline IV push at 2 ml/minute
Normal Saline
|
|
| Secondary | 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. | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42 |
|
|
|
| Secondary | 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. | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in FIQR score at Day 42 |
|
|
|
| Secondary | 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. | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42 |
|
|
|
| Secondary | Change in Fatigue Visual Numeric Scale | Scores range from 0 to 10, with the higher score indicating more fatigue. | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in Fatigue Visual Numeric Scale at Day 42 |
|
|
|
| Secondary | Change in Iron Indices, Serum Ferritin | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | ug/L | Change from Baseline in Iron Indices, Serum ferritin at Day 42 |
|
|
|
| Secondary | Change in Iron Indices - Transferrin Saturation | Patients without a particular measure at a required time point were excluded from the analysis of that measure. | Posted | Mean | Standard Deviation | percent of transferrin saturation | Change from baseline in Iron Indices, Transferrin saturation, at Day 42 |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 16 |
| 41 |
| EG001 | Placebo | 15 cc of Normal Saline IV push at 2 ml/minute Placebo: Normal saline solution | 0 | 40 | 0 | 40 | 2 | 40 |
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |