Safety of Fentanyl TAIFUN Treatment

NCT00822614 | Unknown Phase 3

• 1 other identifier: CL_700_014
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Breakthrough Cancer Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Current BTP Medication

Drug: Opioid

Fentanyl TAIFUN

EXPERIMENTAL

Titration for dose confirmation followed by observation period

Drug: Fentanyl TAIFUN

Interventions

Fentanyl TAIFUN DRUG

Inhalation of Fentanyl via TAIFUN inhaler

Fentanyl TAIFUN

Opioid DRUG

Current optimized BTP treatment

Also known as: Fentanyl transdermal, Morphine Sulfate, Hydromorphone, Oxycodone

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akela Pharma, Inc.: lead

Study Sites (1)

NZOZ

Włocławek, Wolnosc, 4487-800, Poland

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Analgesics, Opioid; Morphine; Hydromorphone; Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Central Study Contacts

Donna J Fordham

CONTACT

941 742 6585; fordhamd@akelapharma.com

Ed E Margerrison, PhD

CONTACT

512 517 9610; margerrisone@akelapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 14, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

PL (1)