A Multicentre, Multinational, Open-Label Trial (including Double-Blind, Placebo-Controlled Cross-Over Extension Part) to Evaluate the Time to Significant Pain Relief with Fentanyl TAIFUN® in the Treatment of Breakthrough Pain in Patients with Cancer on Maintenance Opioid Therapy for Persistent Pain. - FIND 2: Fentanyl Inhalation in Neoplastic Disease

• Conditions: Patients with cancer having episodes of breakthrough pain; MedDRA version: 7.1Level: cancClassification code 10058019

• Registration Number: EUCTR2005-002544-25-FI
• Lead Sponsor: AB Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1.Confirmed diagnosis of cancer
2.Age 18 years or more
3.Using a fixed dose of around-the-clock opioid or a combination of opioids for pain relief; either morphine 60-600mg/day, oxycodone 60-600 mg/day, methadone 15-200mg/day, transdermal fentanyl 25-300?g /hr or 12-120 mg/day hydromorphone, which has been stable for at least 5 days prior to the start of titration visit
4.Experiencing at least 1 episode of target breakthrough pain per day, which is responsive to short-acting opioid therapy
5.Written informed consent has been obtained

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

1.Uncontrolled or rapidly increasing pain
2.Uncontrolled or rapidly increasing background pain
3.Intracranial tumours or cerebral metastases
4.Asthma
5.Inadequate lung function, as defined by PEFR <60% of age-adjusted normal, or any other valid method judged by the investigator appropriate
6.Radiotherapy to the thorax within 30 days of the start of titration visit
7.Chemotherapy with a drug not used before in this patient within 30 days of the registration visit
8.Planned surgery during the study period
9.Known allergy or hypersensitivity to any of the drugs under investigation or their components
10.Any known contraindications to any of the drugs under investigation
11.Alcohol or drug abuse
12.Participation in any clinical study within 1 month of the start of titration visit, with the only exception of the study FIND (EUDRACT No. 2004-001620-21)
13.Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the subject to complete the assessments
14.Any clinical condition which, in the opinion of the investigator would not allow safe completion of the study or safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of background opioidi therapy).
15.Pre-menopausal women (last menstruation ?1 year prior to the screening visit) who:
a.are not surgically sterile and/or
b.have a positive pregnancy test at the randomisation visit and/or
c.are of childbearing potential and are not practicing an acceptable means of birth control or do not plan to continue using this method throughout the study and/or
d.are nursing

Study & Design

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