Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.Phase 3NCT00279344
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)
A Phase 3 study testing Fentanyl (Matrifen) in people with Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain., run by Nycomed.
Trial summary
Primary objectives: To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment To assess the safety of FITpatch compared to standard opioid treatment Secondary objectives: To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
- What is being tested?
- Fentanyl (Matrifen)
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Aug 2007
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50.
- Subject informed consent given.
- Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
- No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
- No impaired respiratory function nor neurological or psychiatric impairment.
- No known abuse of drug, narcotic or alcohol.
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- Not pregnant or nursing.
- Not hypersensitive/allergic to fentanyl or morphine.
- No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
- Not participating in other clinical trials.
Who cannot join
- All exclusion criteria must be answered No for a patient to participate in the trial.
- Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
- Does the patient have a known abuse of drug, narcotic or alcohol?
- Is the patient pregnant or nursing?
- Has the patient neurological or mental impairment that may compromise data collection?
- Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
- Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
- Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
About this study
Official title: A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.
Primary objectives:
- To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
- To assess the safety of FITpatch compared to standard opioid treatment
Secondary objectives:
- To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
- To assess Quality of life reported with FITpatch compared to standard opioid treatment
- Being tested
- Fentanyl (Matrifen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (Matrifen)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary:
To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment
Secondary outcomes (2)
Secondary:
To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startSep 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.Studies 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
- 220 participants
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Project Management, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279344
- Sponsor's protocol ID
- FT-015-IN
- Status last verified
- May 2012
- First submitted
- 14 Dec 2005
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.
- ClinicalTrials.gov ID
- NCT00279344
- Acronym / sponsor ID
- FT-015-IN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Jan 2006 (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.
Primary objectives:
- To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
- To assess the safety of FITpatch compared to standard opioid treatment
Secondary objectives:
- To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
- To assess Quality of life reported with FITpatch compared to standard opioid treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50.
- Subject informed consent given.
- Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
- No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
- No impaired respiratory function nor neurological or psychiatric impairment.
Key exclusion criteria (8 listed)
- All exclusion criteria must be answered No for a patient to participate in the trial.
- Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
- Does the patient have a known abuse of drug, narcotic or alcohol?
- Is the patient pregnant or nursing?
- Has the patient neurological or mental impairment that may compromise data collection?
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 (Matrifen) | Drug | – |
Primary outcome
Primary:
To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment
2 secondary outcomes
Secondary:
To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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.
Nycomed Clinical Project Management study chair
Headquaters
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl (Matrifen) in people with Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain., run by Nycomed.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary:. 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 7 May 2012.