Breakthrough Cancer PainPhase 3FINDSNCT00822614
Safety of Fentanyl TAIFUN Treatment
A Phase 3 study testing Fentanyl TAIFUN and Opioid in people with Breakthrough Cancer Pain, run by Akela Pharma, Inc. at 1 site in Poland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- What is being tested?
- Fentanyl TAIFUN and Opioid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Karofsky Performance Status of 40 or better
- Life expectancy of at least 12 weeks
- Written Informed Consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
NZOZ
Włocławek, Wolnosc, 4487-800
Zbigniew Kaczmarek, MD
About this study
Official title: The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients
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
- Being tested
- Fentanyl TAIFUN, Opioid
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl TAIFUNDrug
Inhalation of Fentanyl via TAIFUN inhaler
OpioidDrug
Also called Fentanyl transdermal, Morphine Sulfate, Hydromorphone, Oxycodone
Current optimized BTP treatment
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Current BTP Medication Receives: Drug: Opioid |
| Fentanyl TAIFUN | Experimental | Titration for dose confirmation followed by observation period Receives: Drug: Fentanyl TAIFUN |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE Profile
Measured: 28 Days
To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile
Measured: 28 days
Secondary outcomes (4)
To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN
Measured: 28 Days
To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose
Measured: 28 Days
To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication
Measured: 28 Days
To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akela Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822614
- Sponsor's protocol ID
- CL_700_014
- Acronym
- FINDS
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT00822614
- Acronym / sponsor ID
- FINDS / CL_700_014
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Akela Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: OpioidCurrent BTP Medication |
| Fentanyl TAIFUN | Experimental | Drug: Fentanyl TAIFUNTitration for dose confirmation followed by observation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl TAIFUNInhalation of Fentanyl via TAIFUN inhaler | Drug | Fentanyl TAIFUN |
| OpioidAlso: Fentanyl transdermal, Morphine Sulfate, Hydromorphone, OxycodoneCurrent optimized BTP treatment | Drug | Active Comparator |
Primary outcome
AE Profile
Time frame: 28 Days
To characterize the safety of Fentanyl TAIFUN treatment vs. the current BTP treatment based on the AE profile
Time frame: 28 days
4 secondary outcomes
To estimate the proportion of patients taht can be titrated to an effective dose of Fentanyl TAIFUN
Time frame: 28 Days
To evaluate the efficacy of Fentanyl TAIFUN with the titrated dose and the current BTP treatment with the confirmed dose
Time frame: 28 Days
To evaluate patients's preference between Fentanyl TAIFUN and the baseline BTP medication
Time frame: 28 Days
To evaluate the sustained analgesic effect of Fentanyl TAIFUN and the current BTP treatment
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl TAIFUN and Opioid in people with Breakthrough Cancer Pain, run by Akela Pharma, Inc. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna J Fordham (941 742 6585, fordhamd@akelapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE Profile (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.