We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02409459
First Posted: April 6, 2015
Last Update Posted: December 13, 2017
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.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Iron Deficiency Fibromyalgia Drug: Injectafer Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • FIQR [ 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.

  • 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.

  • 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.

  • Iron Indices, Serum Ferritin [ Time Frame: Change from Baseline in Iron Indices, Serum ferritin at Day 42 ]
  • Iron Indices - Transferrin Saturation [ Time Frame: Change from baseline in Iron Indices, Transferrin saturation, at Day 42 ]

Enrollment: 81
Study Start Date: March 2015
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Injectafer
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
Drug: Injectafer
Other Name: Ferric Carboxymaltose (FCM)
Placebo Comparator: Placebo
15 cc of Normal Saline IV push at 2 ml/minute
Drug: Placebo
Normal saline solution
Other Name: Saline solution

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Tennessee
Clinical Research Solutions
Franklin, Tennessee, United States, 37064
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Sumita Chowdhury, MD Luitpold Pharmaceuticals
  More Information

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02409459     History of Changes
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: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Anemia, Iron-Deficiency
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics