Safety of Fentanyl TAIFUN Treatment

Breakthrough Cancer Pain Clinical Trial

— FINDS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00822614
• Other study ID #: CL_700_014
• Status: Recruiting
• Phase: Phase 3
• First received: January 12, 2009
• Last updated: January 13, 2009
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2009
• Source: Akela Pharma, Inc.
• Contact: Donna J Fordham
• Phone: 941 742 6585
• Email: fordhamd[@]akelapharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFinland: Finnish Medicines AgencyPoland: Ministry of HealthIndia: Directorate General of Health Services (Drugs Control Section)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breakthrough Cancer Pain

Intervention

Drug:
• Fentanyl TAIFUN
Inhalation of Fentanyl via TAIFUN inhaler
• Opioid
Current optimized BTP treatment

Locations

Country	Name	City	State
Poland	NZOZ	Wloclawek	Wolnosc

Sponsors (1)

Lead Sponsor	Collaborator
Akela Pharma, Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE Profile		28 Days	Yes
Primary	To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile		28 days	Yes
Secondary	To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN		28 Days	No
Secondary	To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose		28 Days	No
Secondary	To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication		28 Days	No
Secondary	To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment		28 Days	No