Open Label Study (Phase III) of NS-32 in Patients with Iron Deficiency Anemia Associated with Gastrointestinal Diseases
Phase 3
Completed
- Conditions
- Iron Deficiency Anemia
- Registration Number
- JPRN-jRCT2080224507
- Lead Sponsor
- ippon Shinyaku Co., Ltd.
- Brief Summary
There was a significant difference in the maximum change in hemoglobin concentration from baseline for the primary endpoint. The same results were seen in both the NS-32 bolus and drip groups. Related TEAEs reported in >=5% of subjects in the overall population were hypophosphatemia, urticaria, and pyrexia. All events were mild or moderate and all resolved. These related TEAEs were effectively managed with standard treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients confirmed with gastrointestinal bleeding due to gastrointestinal diseases and diagnosed with IDA
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
- Secondary Outcome Measures
Name Time Method