Trial Information

Summary: COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

Status: Completed

Protocol Number: ML20339

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.

Brief Summary: This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 50.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Single Blind
• Control: Active
• Assignment: Crossover
• Endpoints: Safety/Efficacy

Study Type:

Condition: Anemia

Intervention Type: Drug

Intervention Name: epoetin beta [NeoRecormon]

Primary Outcome: 1. Local pain due to s.c. injection (by VAS). Time frame: After each injection

Key Secondary Outcomes: 1. Patient preference. Time frame: At end of study 2. AEs, vital signs. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 09/18/2006

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 3:00:33 PM