A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray)Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy - ND

• Conditions: Cancer subjects who experience on average, but not necessarily every day, 1 to 4 episodes of BTCP per day while taking at least 60 mg per day of oral morphine (or equivalent opioid) for their underlying cancer pain will be eligible to enrol into an initial open-label, dose-titration phase.; MedDRA version: 6.1Level: PTClassification code 10058019

• Registration Number: EUCTR2006-003493-97-IT
• Lead Sponsor: ARCHIMEDES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Male or female subjects, aged 18 years and older, with a malignancy who are taking regular, 24-hour medication (at least 60 mg oral morphine or equivalent opioid) for his or her underlying persistent cancer pain and who typically have 1 to 4 episodes of BTCP per day are eligible for participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with uncontrolled or rapidly escalating pain or whose condition is unstable or rapidly deteriorating should not be enrolled. Additionally, subjects with a medical condition (i.e., respiratory, cardiac, hepatic or renal, neurological, psychiatric) that would make them unsuitable for the study should not be enrolled. Subjects with a history of alcohol or substance abuse or who have had radiotherapy within 30 days are not eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified