An Open-Label Study Investigating Long-Term Safety andTolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in theTreatment of Breakthrough Cancer Pain (BTCP) in SubjectsTaking Regular Opioid Therapy - ND

Conditions: trattamento del dolore oncologico episodico intenso (Breakthrough Cancer Pain, BTCP,) nei soggetti in terapia analgesica con oppioidi assunta regolarmente
MedDRA version: 6.1Level: PTClassification code 10058019

Registration Number: EUCTR2006-005403-34-IT

Lead Sponsor: ARCHIMEDES

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

If enrolled in Studies CP043/06/FCNS or CP044/06/FCNS:

a. Subject successfully completed the study (including the return of any

remaining drug supplies and successful completion of the subject

diaries).

b. Subject is continuing to experience episodes of breakthrough pain

that were adequately controlled with a designated dose of Nasalfent

in Studies CP043/06/FCNS or CP044/06/FCNS.

c. The subject?s medical condition is such that the subject continues to

meet the other inclusion/exclusion criteria listed.

If newly enrolled into this study:

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) no
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 are not eligible.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to investigate the long-term safety, tolerability, and<br><br>acceptability of Nasalfent in the treatment of BTCP.;Secondary Objective: ND;Primary end point(s): Withdrawal due to AEs.<br><br>Physical examination, including vital signs.<br><br>Laboratory assessments.<br><br>Subject acceptability assessments.

Secondary Outcome Measures