Pain, IntractablePhase 3NCT00216684
Phase III Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Chronic Intractable Pain- Assessment of Effectiveness, Safety and Pharmacokinetics
A Phase 3 study testing fentanyl in people with Pain, Intractable, run by Janssen Pharmaceutical K.K..
Trial summary
The purpose of this study is to verify the effectiveness, and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been switched from existing formulations, such… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Intractable
- What is being tested?
- fentanyl
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Sep 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic intractable pain receiving any of the following treatments :(1)Codeine phosphate, (2)Morphine hydrochloride preparations equivalent to less than 315 mg/day of oral morphine, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day
- Patients with chronic intractable pain in whom lesions causative of pain cannot be removed or treated, or in whom pain has been persisting for at least 12 weeks despite of the existing medication
- Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patches (patients may be ambulatory when the study starts).
Who cannot join
- Patients with respiratory dysfunction such as chronic pulmonary disease
- Patients with asthma
- Patients with bradyarrhythmia
- Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period
- Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor
- Patients with any psychoneurologic complication and judged incapable of self assessment
- Patients with or with a history of drug dependency or narcotic abuse
- Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic
About this study
Official title: An Open Label Study to Confirm the Effectiveness, and Safety of Fentanyl Transdermal Matrix Patch in Japanese Patients With Chronic Intractable Pain Who Has Prior Therapy of Codeine, Morphine Hydrochloride, or Fentanyl Injectable Preparations.
The purpose of this study is to verify the effectiveness, and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks are to be assessed, if possible.
Read the detailed description
Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, fentanyl transdermal matrix patch is not liable to leakage of drug solution and does not contain alcohol, which becomes a cause of skin irritation. Also this new formulation has become available in a smaller dose of 12.5mg/hr while the smallest Durotep® Patch is 25mg/hr. While Durotep® Patch is currently indicated only for cancer pain in Japan, this clinical trial was planned to assess effectiveness, and safety of fentanyl transdermal matrix patch in Japanese patients with chronic intractable pain receiving codeine, morphine hydrochloride, or fentanyl injectable formulations. After pre-treatment period for seven to fourteen days for evaluating the eligibility of the patients for the study, patients will be treated for 4 weeks as Treatment period 1 and 48 weeks as Treatment period 2 followed by 3-day post-treatment observation period. One patch can be used for 72 hours, which is the same as the existing Patch. Starting from the first day of treatment, fentanyl will be applied to the chest, the upper arm or other appropriate site, which will be replaced with a new patch every three days (ca. 72 hr). Starting dose should be between 12.5 mcg/hr and 75 mcg/hr, depending on the prior opioid dose.
- Conditions
- Pain, Intractable
- Being tested
- fentanyl
- Keywords
- Fentanyl, Chronic intractable pain, Japanese patients
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's global assessments of pain on the completion day of Treatment period 1
Secondary outcomes (1)
Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216684
- Sponsor's protocol ID
- CR004879
- Status last verified
- Jan 2011
- First submitted
- 13 Sep 2005
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Confirm the Effectiveness, and Safety of Fentanyl Transdermal Matrix Patch in Japanese Patients With Chronic Intractable Pain Who Has Prior Therapy of Codeine, Morphine Hydrochloride, or Fentanyl Injectable Preparations.
- ClinicalTrials.gov ID
- NCT00216684
- Acronym / sponsor ID
- CR004879
- Conditions
- Pain, Intractable
- Keywords
- Fentanyl, Chronic intractable pain, Japanese patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 22 Sep 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 verify the effectiveness, and safety in Japanese patients with chronic intractable pain after 4-week medication of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, or 100 mcg/hr, who have been switched from existing formulations, such as codeine, morphine hydrochloride, or fentanyl injectable. Furthermore, the safety and effectiveness of long term treatment such as 48 weeks are to be assessed, if possible.
Detailed description
Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, fentanyl transdermal matrix patch is not liable to leakage of drug solution and does not contain alcohol, which becomes a cause of skin irritation. Also this new formulation has become available in a smaller dose of 12.5mg/hr while the smallest Durotep® Patch is 25mg/hr. While Durotep® Patch is currently indicated only for cancer pain in Japan, this clinical trial was planned to assess effectiveness, and safety of fentanyl transdermal matrix patch in Japanese patients with chronic intractable pain receiving codeine, morphine hydrochloride, or fentanyl injectable formulations. After pre-treatment period for seven to fourteen days for evaluating the eligibility of the patients for the study, patients will be treated for 4 weeks as Treatment period 1 and 48 weeks as Treatment period 2 followed by 3-day post-treatment observation period. One patch can be used for 72 hours, which is the same as the existing Patch. Starting from the first day of treatment, fentanyl will be applied to the chest, the upper arm or other appropriate site, which will be replaced with a new patch every three days (ca. 72 hr). Starting dose should be between 12.5 mcg/hr and 75 mcg/hr, depending on the prior opioid dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic intractable pain receiving any of the following treatments :(1)Codeine phosphate, (2)Morphine hydrochloride preparations equivalent to less than 315 mg/day of oral morphine, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day
- Patients with chronic intractable pain in whom lesions causative of pain cannot be removed or treated, or in whom pain has been persisting for at least 12 weeks despite of the existing medication
- Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patches (patients may be ambulatory when the study starts).
Key exclusion criteria (8 listed)
- Patients with respiratory dysfunction such as chronic pulmonary disease
- Patients with asthma
- Patients with bradyarrhythmia
- Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period
- Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor
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 | Drug | – |
Primary outcome
Patient's global assessments of pain on the completion day of Treatment period 1
1 secondary outcome
Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics
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 1 Feb 2011.
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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.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fentanyl in people with Pain, Intractable, run by Janssen Pharmaceutical K.K..
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 3 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 1 Feb 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?
Patient's global assessments of pain on the completion day of Treatment period 1. 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 1 Feb 2011; AzTrials last refreshed its copy on 7 Nov 2026.