Trial Details
Not RecruitingBasic Information
| Clinical ID | c5104 |
|---|---|
| Identifier | EUCTR2014-001518-25-DE |
| Trial Title | A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer) against Placebo in Subjects with Iron Deficiency Anaemia and who are Intolerant or Unresponsive to Oral Iron Therapy |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NULL |
|---|---|
| Conditions | Subjects with iron deficiency anaemia (IDA) caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leadi |
| Interventions | Trade Name: MonoferPharmaceutical Form: Solution for injectionINN or Proposed INN: Iron Isomaltoside 1000CAS Number: 1370654-58-2Other descriptive name: IRON ISOMALTOSIDE 1000Concentration unit: mg/ml milligram(s)/millilitreCon |
Participant Information
| Sponsor | Pharmacosmos A/S |
|---|---|
| City | NULL |
| Country/Region | United States;Russia;Germany;United Kingdom |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | NULL |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |