FINDS: Safety of Fentanyl TAIFUN Treatment

Sponsor

Akela Pharma, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00822614

Collaborator

(none)

500

Enrollment

Location

Arms

Duration (Months)

38.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breakthrough Cancer Pain	Drug: Fentanyl TAIFUN Drug: Opioid	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jan 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Active Comparator

Current BTP Medication

Drug: Opioid

Current optimized BTP treatment

Other Names:

Fentanyl transdermal

Morphine Sulfate

Hydromorphone

Oxycodone

Experimental: Fentanyl TAIFUN

Titration for dose confirmation followed by observation period

Drug: Fentanyl TAIFUN

Inhalation of Fentanyl via TAIFUN inhaler

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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