Safety of Fentanyl TAIFUN Treatment

Phase 3

• Conditions: Breakthrough Cancer Pain
• Interventions: Drug: Opioid; Drug: Fentanyl TAIFUN

• Registration Number: NCT00822614
• Lead Sponsor: Akela Pharma, Inc.

Brief Summary

A Multicenter, Multinational, Randomized, Open-Label, Parallel-Group Trial to Evaluate hte 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14
• Primary Completion: 2009-12
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 18 Years or older
• A medically documented diagnosis of cancer
• Use of a fixed round the clock dose of opioid as maintenance therapy with a dose equivalence of at least 60mg of oral morphine/ day, or at least 25 mcg 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 randomization
• Current use of opioid medication for BTP
• At least 4 episodes of BTP per week, with peak intensity of at least 4 on the NPS at pain onset. No more than 4 BTP episodes per day.
• PIFR of at least 20L/min
• Karofsky Performance Status of 40 or better
• Life expectancy of at least 12 weeks
• Written Informed Consent

Exclusion Criteria

• Uncontrolled or rapidly increasing BTP
• Symptomatic intracranial tumors or cerebral metastases
• Persistent symptomatic asthma
• Patients unable to use the inhaler
• Inadequate lung function, as defined by PEFR <60%
• Hypersensitivities, allergies or contraindications to fentanyl or the study medication components
• A recent history of alcohol or substance abuse (in the past 1 year)
• Radiotherapy to the thorax within 30 days of the beginning of the titration phase
• Cognitive impairment or any neurological of psychiatric disease which could compromise the ability of the patient to complete the assessments
• Participation in any clinical study with an experimental drug within 30 days of randomization
• Any clinical condition 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
• Pre-menopausal women who are not surgically sterile and/or have a positive pregnancy test at baseline visit and/ or are of child bearing potential and are not using a reliable method of birth control or do not plan to continue using this method throughout the study and/or who are nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Opioid	Current BTP Medication
Fentanyl TAIFUN	Fentanyl TAIFUN	Titration for dose confirmation followed by observation period

Primary Outcome Measures

Name	Time	Method
AE Profile	28 Days
To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile	28 days

Secondary Outcome Measures

Name	Time	Method
To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN	28 Days
To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose	28 Days
To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication	28 Days
To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment	28 Days

Trial Locations

Locations (1)

NZOZ; 🇵🇱 Wloclawek, Wolnosc, Poland