PainPhase 2NCT00355628
Clinical Study of KW-2246 in Patients With Cancer Pain
A Phase 2 study testing KW-2246 (fentanyl citrate) in people with Pain and Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- What is being tested?
- KW-2246 (fentanyl citrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent to participate in the study.
- Be able to be hospitalized.
- Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
- Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
- Not have experienced intolerable toxicity for 2 days before study entry.
- Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
- Have a life expectancy of at least 1 month after the start of KW-2246 administration.
- Considered to be able to keep the patient diary.
Who cannot join
- Serious respiratory dysfunction.
- Asthma.
- Serious bradyarrhythmia.
- Serious hepatic or renal dysfunction.
- Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
- History of convulsive seizures (except a single episode of infantile febrile convulsions).
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- Current or past history of drug dependence or narcotic abuse.
- Dry mouth that affects oral intake.
- Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
- Use of narcotic antagonists within 7 days prior to study entry.
- Interventions that may affect pain evaluation, such as surgery, radiation to the pain site (including those sites that influence pain) and nerve block, within 7 days prior to study entry or scheduled to be given during the study.
- Patients with a history of serious adverse reactions to the combination of opioid analgesics and other drugs/substances who are currently receiving or expected to receive those drugs/substances combined to opioid analgesics.
- History of hypersensitivity to fentanyl.
- Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
- Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
- Prior exposure to KW-2246.
- Patients whom an investigator judge unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study of KW-2246 in Patients With Cancer Pain - Maintenance Switch Study in Oral Morphine or Oral Oxycodone-treated Patients
This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients.
Read the detailed description
This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.
- Being tested
- KW-2246 (fentanyl citrate)
- Keywords
- Pain, Cancer, Neoplasm, Continual Reassessment Method, Pain Associated with Cancer/Neoplasms
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-2246 (fentanyl citrate)Drug
Also called Fentanyl citrate
KW-2246
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | KW-2246 (fentanyl citrate) Receives: Drug: KW-2246 (fentanyl citrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Measured: At every visit
Pain Intensity as Rated on a Categorical Scale
Measured: At specified visits
Secondary outcomes (3)
Pain Intensity as Rated on a Visual Analog Scale (VAS)
Measured: At specified visits
Number of Rescue Doses per Day
Measured: At every visit
Regular Dose Level of KW-2246
Measured: At every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2007
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.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355628
- Sponsor's protocol ID
- 2246-0401
- Status last verified
- Aug 2012
- First submitted
- 21 Jul 2006
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of KW-2246 in Patients With Cancer Pain - Maintenance Switch Study in Oral Morphine or Oral Oxycodone-treated Patients
- ClinicalTrials.gov ID
- NCT00355628
- Acronym / sponsor ID
- 2246-0401
- Keywords
- Pain, Cancer, Neoplasm, Continual Reassessment Method, Pain Associated with Cancer/Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- First posted
- 24 Jul 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.
This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients.
Detailed description
This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: KW-2246 (fentanyl citrate)KW-2246 (fentanyl citrate) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent to participate in the study.
- Be able to be hospitalized.
- Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
- Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
- Not have experienced intolerable toxicity for 2 days before study entry.
Key exclusion criteria (17 listed)
- Serious respiratory dysfunction.
- Asthma.
- Serious bradyarrhythmia.
- Serious hepatic or renal dysfunction.
- Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and 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 |
|---|---|---|
| KW-2246 (fentanyl citrate)Also: Fentanyl citrateKW-2246 | Drug | 1 |
Primary outcome
Safety and Tolerability
Time frame: At every visit
Pain Intensity as Rated on a Categorical Scale
Time frame: At specified visits
3 secondary outcomes
Pain Intensity as Rated on a Visual Analog Scale (VAS)
Time frame: At specified visits
Number of Rescue Doses per Day
Time frame: At every visit
Regular Dose Level of KW-2246
Time frame: At every visit
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 31 Aug 2012.
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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.
Study Director study director
Kyowa Kirin Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KW-2246 (fentanyl citrate) in people with Pain and Cancer, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 8 inclusion and 17 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 31 Aug 2012. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and Tolerability (time frame: At every visit). 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 31 Aug 2012.