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Patient Preference for Pegfilgrastim (Neulasta®) Application Forms

NCT03619993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2019-12-17

No results posted yet for this study

Summary

The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Chemotherapy will be supported with pegfilgrastim for four subsequent chemotherapy cycles using alternating application forms.

Conditions

Interventions

DEVICE

On-body injector

Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.

DEVICE

Pre-filled syringe

For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • Michael Metz, Dr. med. · OSP Göttingen - Gemeinschaftspraxis Dres. Meyer, Ammon, Metz und Müller

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2019-09-10
Completion
2019-09-10

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619993 on ClinicalTrials.gov