Safety of Fentanyl TAIFUN Treatment

Condition(s) targeted: Breakthrough Cancer Pain

Intervention: Fentanyl TAIFUN (Drug); Opioid (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Akela Pharma, Inc.

Overall contact:
Donna J Fordham, Phone: 941 742 6585, Email: fordhamd@akelapharma.com

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AE Profile

To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile

Secondary outcome:

To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN

To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose

To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication

To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Donna J Fordham, Phone: 941 742 6585, Email: fordhamd@akelapharma.com

NZOZ, Wloclawek, Wolnosc 4487-800, Poland; Recruiting
Zbigniew Kaczmarek, MD

Starting date: December 2008
Last updated: January 13, 2009