Anemia / Iron Deficiency Study (1 mo to 17 yrs)

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Purpose: 

The objective of the study is to compare the safety and gastrointestinal tolerability of ferric maltol oral suspension and ferrous sulfate oral liquid in children and adolescents aged 2 years to 17 years, and assess the safety and tolerability of ferric maltol oral suspension in children 1 month to less than 2 years, in the treatment of iron deficiency anemia during the 12 weeks treatment period. 

What to Expect: 

Participation in the anemia / iron deficiency study lasts approximately 12 weeks and includes visits to the study site. Qualifying participants may be compensated for their time and travel.

Eligibility Criteria: 

Participant must: 

• Be between the ages of 1 month to 17 years at time of informed consent.
• Be willing and able to comply with the study requirements and provide written informed consent. In the case of patients under the age of legal consent, the legal guardian(s) must provide informed consent and the patient should provide assent per local and national requirements. 
• Have iron deficiency anemia as measured by the central laboratory at the screening visit.
• Female subjects of childbearing potential must agree to use a highly effective method of contraception (which includes complete abstinence) until study completion and for at least 4 weeks following their final study visit. Highly effective contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), a vasectomized partner and oral contraceptive medications.

Length / Duration:  

Participation in this comparative study lasts approximately 12 weeks and includes follow up visits to the study site and supervised dosing by parent/legal guardian for children/adolescents throughout the treatment period and recorded on a dosing diary.

Location:  

3229 Hillsdale Lane, Kissimmee, Florida 34741, United States

Who should you contact: 

Recruitment Department: (407) 350-3979