Expired Study
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Franklin, Tennessee 37064


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.


Study summary:

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.


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.


NCT ID:

NCT02409459


Primary Contact:

Study Director
Mark A Falone, MD
Luitpold Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Franklin, Tennessee 37064
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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