Confirmatory Open-label Saccharated Iron Oxide-controlled Study of NS-32 in Patients with Iron Deficiency Anemia Associated with Menorrhagia (Phase III)
Phase 3
Completed
- Conditions
- Iron Deficiency Anemia
- Registration Number
- JPRN-jRCT2080224508
- Lead Sponsor
- ippon Shinyaku Co., Ltd.
- Brief Summary
The maximum change in hemoglobin concentration from baseline, as the primary endpoint, was noninferior for NS-32 compared with control. The incidence of TEAEs was lower in the NS-32 group than in the Control group. The incidences of pyrexia and urticaria were higher in the NS-32 group than in the Control group ; both TEAEs are known adverse drug reactions of ferric derisomaltose. No severe TEAEs of pyrexia or urticaria were reported. These TEAEs were effectively managed with standard treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 357
Inclusion Criteria
Patients diagnosed with IDA associated with menorrhagia
Exclusion Criteria
Patients with anemia due to causes other than iron deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Maximum change in hemoglobin concentration
- Secondary Outcome Measures
Name Time Method efficacy<br>The duration in which the change in hemoglobin concentration<br>efficacy<br>Percentage of subjects whose hemoglobin concentration has increased by >=2 g/dL<br>efficacy<br>Percentage of subjects with hemoglobin concentration of >= 12.0 g/d