A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group 12-Week Trial to Evaluate the Safety of Fentanyl TAIFUN® Treatment after Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients on Maintenance Opioid Therapy. - FINDS3

• Conditions: Breakthrough pain in opioid tolerant cancer patients; MedDRA version: 11.0Level: LLTClassification code 10064556Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-007964-40-FI
• Lead Sponsor: AKELA Pharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Age 18 years or older.
2.A medically documented diagnosis of cancer.
3.Use of a fixed around-the-clock dose of opioid or a fixed combination of opioids as maintenance therapy for pain relief with a dose equivalent of at least 60 mg of oral morphine/day, or at least 25 µg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily or at least 8 mg of oral hydromorphone daily. Current opioid treatment for at least 7 days prior to the randomization.
4.Current use of opioid medication for BTP.
5.At least 4 episodes of BTP per Week with peak intensity of at least 4 on the numerical pain scale (NPS) at pain onset. No more than 4 BTP episodes per Day.
6.The flow rate of inhalation of at least 20 L/min assessed by inspiratory flow meter (the highest of two readings will be used).
7.Karnofsky Performance Status 40 or better.
8.Life expectancy of at least 12 weeks.
9.Written informed consent.
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 BTP.
2.Symptomatic intracranial tumors or cerebral metastases.
3.Persistent, symptomatic asthma despite medication, as defined by daily symptoms, frequent exacerbations, frequent nocturnal asthma symptoms, predicted FEV1 < 60% or personal best PEFR < 60%.
4.Patients unable to use the inhaler (based on investigator’s opinion).
5.Inadequate lung function, as defined by PEFR < 60 %.
6.Hypersensitivities, allergies or contraindications to fentanyl or the study medication components.
7.A recent history of alcohol or substance abuse (in the past 1 year).
8.Radiotherapy to the thorax within 30 days of the beginning of the titration phase.
9.Cognitive impairment or any neurological or psychiatric disease which could compromise the ability of the patient to complete the assessments.
10.Participation in any clinical study with an experimental drug within 30 days of the randomization.
11.Any clinical condition (e.g. severe hepatic impairment) or medical history which, in the opinion of the investigator would not allow for the safe completion of the study or the safe administration of the study drug (e.g. elderly or cachectic patient on the lowest dose of maintenance opioid therapy).
12.Pre-menopausal women (last menstruation < 1 year prior to the screening visit) who:
•are not surgically sterile and/or
•have a positive pregnancy test at baseline visit and/or
•are of childbearing potential and are not using reliable means of birth control or do not plan to continue using this method throughout the study and/or are nursing.

Study & Design

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