Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With… (NCT02409459) | Clinical Trial Compass
CompletedPhase 2
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
United States81 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
*…
What they're measuring
1
Proportion of Patients With a ≥13 Point Improvement in FIQR Score