PainPhase 3NCT00269737
Efficacy of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer
A Phase 3 study testing Fentanyl Transdermal Therapeutic System (TTS) in people with Pain and Cancer, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fentanyl Transdermal Therapeutic System (TTS)
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- May 1986to Feb 1988
- 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
- Patients with a diagnosis of intermediate stage of malignancy, operationally defined as non-localized or metastatic disease causing moderate to severe pain
- Having a diagnosis of terminal disease, defined as life expectancy of six months or less, with moderate to severe pain associated with malignancy
- Requiring treatment with a narcotic analgesic for relief of cancer pain
- Having normal liver, kidney, and lung function, as determined by liver function tests, BUN, creatinine, and blood gases
Who cannot join
- Patients with a history of allergic reaction to narcotics
- Having a history of narcotic abuse prior to cancer diagnosis
- Unable to communicate adequately to provide information assessing the effectiveness of treatment
- Having active skin disease which precludes application of the transdermal system
- Having a history of carbon dioxide (CO2) retention or respiratory problems and who, in the physician's judgment, should not use narcotics
About this study
Official title: Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III
The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.
Read the detailed description
Moderate to severe pain is experienced by about one-third of cancer patients during the intermediate stage of their disease. Currently used medications for the treatment of moderate to severe pain due to cancer often provide inadequate pain relief and require repeated oral administration of a narcotic. Providing prolonged, safe and effective pain relief on a continuous basis would be a major therapeutic advance in the management of cancer pain. This is an open-label pilot study to evaluate the safety and effectiveness of the fentanyl Transdermal Therapeutic System (TTS) in the management of chronic pain in patients with cancer. The initial dose of the fentanyl transdermal patch is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry. Four dosage strengths of the fentanyl transdermal patch are available as study medication, with a nominal delivery rate of 100, 75, 50 and 25 micrograms of fentanyl per hour. Multiple transdermal patches are worn when higher doses are required. Morphine sulfate is available as needed as rescue medication to treat breakthrough pain. After the initial application, the dose is titrated for each patient within a hospital setting over the course of 3 days, or as long as is necessary to achieve adequate pain control. Changes in dose during titration occur no more frequently than once every 24 hours. After an appropriate dose is reached, the transdermal patch is replaced every 72 hours with a new transdermal patch, applied to a fresh skin site. When discharged, patients enter a 3-week program of twice weekly nursing visits to monitor patient progress. Patients are evaluated at designated time intervals for pain intensity, vital signs, and serum fentanyl concentration. Records are kept of all concomitant medications administered during the study and any adverse events. After completion of the 3-week program, patients are given the opportunity to remain on the fentanyl Transdermal Therapeutic System (TTS) for long-term treatment of their chronic pain.
The TTS (fentanyl) transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry, titrated as needed to achieve adequate pain control. The patch is replaced every 72 hours. The treatment phase is 3 weeks.
- Being tested
- Fentanyl Transdermal Therapeutic System (TTS)
- Keywords
- fentanyl, pain, Cancer, patch
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Transdermal Therapeutic System (TTS)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at designated time intervals
Secondary outcomes (1)
Pharmacokinetics; Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startMay 1986
- Study completionFeb 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, Alza Corporation, DE, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269737
- Sponsor's protocol ID
- CR005980
- Status last verified
- Apr 2010
- First submitted
- 22 Dec 2005
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III
- ClinicalTrials.gov ID
- NCT00269737
- Acronym / sponsor ID
- CR005980
- Keywords
- fentanyl, pain, Cancer, patch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- May 1986
- Study completion
- Feb 1988
- First posted
- 26 Dec 2005 (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.
The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.
Detailed description
Moderate to severe pain is experienced by about one-third of cancer patients during the intermediate stage of their disease. Currently used medications for the treatment of moderate to severe pain due to cancer often provide inadequate pain relief and require repeated oral administration of a narcotic. Providing prolonged, safe and effective pain relief on a continuous basis would be a major therapeutic advance in the management of cancer pain. This is an open-label pilot study to evaluate the safety and effectiveness of the fentanyl Transdermal Therapeutic System (TTS) in the management of chronic pain in patients with cancer. The initial dose of the fentanyl transdermal patch is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry. Four dosage strengths of the fentanyl transdermal patch are available as study medication, with a nominal delivery rate of 100, 75, 50 and 25 micrograms of fentanyl per hour. Multiple transdermal patches are worn when higher doses are required. Morphine sulfate is available as needed as rescue medication to treat breakthrough pain. After the initial application, the dose is titrated for each patient within a hospital setting over the course of 3 days, or as long as is necessary to achieve adequate pain control. Changes in dose during titration occur no more frequently than once every 24 hours. After an appropriate dose is reached, the transdermal patch is replaced every 72 hours with a new transdermal patch, applied to a fresh skin site. When discharged, patients enter a 3-week program of twice weekly nursing visits to monitor patient progress. Patients are evaluated at designated time intervals for pain intensity, vital signs, and serum fentanyl concentration. Records are kept of all concomitant medications administered during the study and any adverse events. After completion of the 3-week program, patients are given the opportunity to remain on the fentanyl Transdermal Therapeutic System (TTS) for long-term treatment of their chronic pain.
The TTS (fentanyl) transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry, titrated as needed to achieve adequate pain control. The patch is replaced every 72 hours. The treatment phase is 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of intermediate stage of malignancy, operationally defined as non-localized or metastatic disease causing moderate to severe pain
- Having a diagnosis of terminal disease, defined as life expectancy of six months or less, with moderate to severe pain associated with malignancy
- Requiring treatment with a narcotic analgesic for relief of cancer pain
- Having normal liver, kidney, and lung function, as determined by liver function tests, BUN, creatinine, and blood gases
Key exclusion criteria (5 listed)
- Patients with a history of allergic reaction to narcotics
- Having a history of narcotic abuse prior to cancer diagnosis
- Unable to communicate adequately to provide information assessing the effectiveness of treatment
- Having active skin disease which precludes application of the transdermal system
- Having a history of carbon dioxide (CO2) retention or respiratory problems and who, in the physician's judgment, should not use narcotics
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 Transdermal Therapeutic System (TTS) | Drug | – |
Primary outcome
Pain intensity at designated time intervals
1 secondary outcome
Pharmacokinetics; Incidence of adverse events
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 19 May 2011.
- Efficacy of TTS (fentanyl) in the management of pain in patients with malignancy Study 3Link provided by the sponsor.
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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.
Alza Corporation Clinical Trial study director
Alza Corporation, DE, USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl Transdermal Therapeutic System (TTS) in people with Pain and Cancer, run by Alza Corporation, DE, USA.
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 4 inclusion and 5 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 19 May 2011. 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?
Pain intensity at designated time intervals. 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 19 May 2011.