Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years (GENISIS)

Takeda

Status: Completed

Conditions: Breakthrough Pain; Cancer

Treatments: Drug: Instanyl (Intranasal Fentanyl)

Study type: Observational

Funder types: Industry

Identifiers

NCT00994760

FT-1301-401-DE

Details and patient eligibility

About

The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• decision to start treatment with intranasal fentanyl spray
• written informed consent

Exclusion criteria

• criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Trial design

131 participants in 1 patient group

GENISIS

Treatment:

Drug: Instanyl (Intranasal Fentanyl)