Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE April 1, 2015
First Posted Date  ICMJE April 6, 2015
Results First Submitted Date  ICMJE April 18, 2017
Results First Posted Date  ICMJE December 13, 2017
Last Update Posted Date February 20, 2018
Study Start Date  ICMJE March 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
Proportion of Patients With a ≥13 Point Improvement in FIQR Score [ Time Frame: Day 42 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron Deficiency
  • Fibromyalgia
Intervention  ICMJE
  • Drug: Injectafer
    Other Name: Ferric Carboxymaltose (FCM)
  • Drug: Placebo
    Normal saline solution
    Other Name: Saline solution
Study Arms  ICMJE
  • Experimental: Injectafer
    15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
    Intervention: Drug: Injectafer
  • Placebo Comparator: Placebo
    15 cc of Normal Saline IV push at 2 ml/minute
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
81
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2015)
40
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject's ≥ 18 years of age, able to give informed consent to the study.
  • Fibromyalgia diagnosis based on The 2011 modification of the American College of Rheumatology (ACR) 's 2010 preliminary criteria for diagnosing fibromyalgia (2011ModCr)
  • A baseline score ≥ 60 on the FIQR
  • Subject's current medications to treat fibromyalgia, including pain medicines, anti-depressants, sleep medications must be on a stable dose for at least 30 days.
  • Subject's current narcotic medication must be on a stable dose for at least 30 days prior to randomization
  • Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.

Exclusion Criteria:

  • Parenteral iron use within 4 weeks prior to screening.
  • History of > 10 blood transfusions in the past 2 years.
  • Anticipated need for blood transfusion during the study.
  • Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
  • Current or acute or chronic infection other than viral upper respiratory tract infection
  • Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
  • Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
  • Pregnant or lactating women.
  • Severe peripheral vascular disease with significant skin changes.
  • Seizure disorder currently being treated with medication.
  • Baseline ferritin ≥ 50 ng/mL.
  • Baseline TSAT ≥ 20%.
  • History of hemochromatosis or hemosiderosis or other iron storage disorders.
  • Known positive hepatitis with evidence of active disease.
  • Hemoglobin greater than the upper limit of normal.
  • Calcium or phosphorous outside the normal range.
  • Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
  • Known positive HIV-1/HIV-2 antibodies (anti-HIV)
  • Received an investigational drug within 30 days before randomization.
  • Chronic alcohol or drug abuse within the past 6 months.
  • Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
  • Subject unable to comply with the study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02409459
Other Study ID Numbers  ICMJE 1VIT14038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party American Regent, Inc.
Study Sponsor  ICMJE American Regent, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark A Falone, MD American Regent, Inc.
PRS Account American Regent, Inc.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP