Safety of Fentanyl TAIFUN Treatment (FINDS)

The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients

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

Study Overview

• Status: Unknown
• Conditions: Breakthrough Cancer Pain
• Intervention / Treatment: Drug: Opioid; Drug: Fentanyl TAIFUN

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Wolnosc
    • Wloclawek, Wolnosc, Poland, 4487-800
      • Recruiting
      • NZOZ
      • Contact: Zbigniew Kaczmarek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator; Current BTP Medication	Drug: Opioid; Current optimized BTP treatment; Other Names: Oxycodone; Hydromorphone; Morphine Sulfate; Fentanyl transdermal
EXPERIMENTAL: Fentanyl TAIFUN; Titration for dose confirmation followed by observation period	Drug: Fentanyl TAIFUN; Inhalation of Fentanyl via TAIFUN inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Akela Pharma, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2009
• Study Completion (ANTICIPATED): January 1, 2010

Study Registration Dates

• First Submitted: January 12, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (ESTIMATE): January 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2009
• Last Update Submitted That Met QC Criteria: January 13, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine; Oxycodone; Hydromorphone
• Other Study ID Numbers: CL_700_014