Trial information
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia
Status: Completed
Protocol number: ML19553
Sponsor: Roche Nederland B.V.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind, placebo-controlled study of injection-site pain after administration of NeoRecormon compared with darbepoetin alfa in adult subjects.
Brief summary: A double-blind, placebo controlled, randomized, study of injection-site pain after administration of subcutaneous NeoRecormon compared with darbepoetin alfa in patients. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is
60.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Single Group; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta[NeoRecormon]
Primary outcome: 1. Efficacy: Pain experience on the Visual Analogue Scale
Key secondary outcomes: 1. Efficacy: pain experience on a verbal scale Safety: serious adverse events
Inclusion criteria:
- adult patients >=18 years of age;
- renal anemia;
- clinically stable for >3 months;
- treatment with sc injections of an erythropoiesis-stimulating agents for >3 months.
Exclusion criteria:
- known allergy to any of the study drugs or their components;
- chronic liver disease;
- women who are pregnant or breastfeeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Netherlands
