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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

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.