Loading clinical trials...

UNKNOWNPHASE3

Safety of Fentanyl TAIFUN Treatment

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

NCT00822614•Akela Pharma, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

Locations (1)

NZOZ

Włocławek, Wolnosc, Poland

Key Dates

Start Date

December 1, 2008

Primary Completion Date

December 1, 2009

Completion Date

January 1, 2010

Last Updated

January 14, 2009

Enrollment

500

ESTIMATED participants

Conditions

Breakthrough Cancer Pain

Interventions

Fentanyl TAIFUN

DRUG

Opioid

DRUG

Contacts

Donna J Fordham

CONTACT

941 742 6585 fordhamd@akelapharma.com

Ed E Margerrison, PhD

CONTACT

512 517 9610 margerrisone@akelapharma.com

Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients

NCT03895762

Breakthrough Cancer Pain

View study

COMPLETED

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

NCT01946555

TumorCancer Pain+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions