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Safety of Fentanyl TAIFUN Treatment (FINDS)

Primary Purpose

Breakthrough Cancer Pain

Status

Unknown status

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

Fentanyl TAIFUN

Opioid

About this trial

This is an interventional treatment trial for Breakthrough Cancer Pain focused on measuring Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

NZOZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active Comparator

Fentanyl TAIFUN

Arm Description

Current BTP Medication

Titration for dose confirmation followed by observation period

Outcomes

Primary Outcome Measures

AE Profile

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00822614

First Posted

January 12, 2009

Last Updated

January 13, 2009

Sponsor

Akela Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00822614

Brief Title

Safety of Fentanyl TAIFUN Treatment

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Akela Pharma, Inc.

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breakthrough Cancer Pain

Keywords

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

Current BTP Medication

Arm Title

Fentanyl TAIFUN

Arm Type

Experimental

Arm Description

Titration for dose confirmation followed by observation period

Intervention Type

Drug

Intervention Name(s)

Fentanyl TAIFUN

Intervention Description

Inhalation of Fentanyl via TAIFUN inhaler

Intervention Type

Drug

Intervention Name(s)

Opioid

Other Intervention Name(s)

Fentanyl transdermal, Morphine Sulfate, Hydromorphone, Oxycodone

Intervention Description

Current optimized BTP treatment

Primary Outcome Measure Information:

Title

AE Profile

Time Frame

28 Days

Title

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

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

Time Frame

28 Days

Title

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

Time Frame

28 Days

Title

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

Time Frame

28 Days

Title

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

Time Frame

28 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Donna J Fordham

Phone

941 742 6585

fordhamd@akelapharma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ed E Margerrison, PhD

Phone

512 517 9610

margerrisone@akelapharma.com

Facility Information:

Facility Name

NZOZ

City

Wloclawek

State/Province

Wolnosc

ZIP/Postal Code

4487-800

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zbigniew Kaczmarek, MD

12. IPD Sharing Statement

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Safety of Fentanyl TAIFUN Treatment

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