Pain, CancerPhase 3NCT00683995
A Phase III Clinical Study of KW-2246
A Phase 3 study testing KW-2246 (fentanyl citrate) in people with Pain, Cancer, run by Kyowa Kirin Co., Ltd. at 20 sites in Japan.
Trial summary
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain, Cancer
- What is being tested?
- KW-2246 (fentanyl citrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 20 sitesJapan
- Study dates
- Mar 2008to Oct 2011
- 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 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 on a voluntary basis.
- Patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial.
- Outpatients who live with a caregiver such as a family member, or inpatients.
- Require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator.
- Performance Status (ECOG) of 3 or less at the time of giving written informed consent.
- Have a life expectancy of at least three months as determined by the investigator.
- Be able to receive diary training and have been able to properly complete diaries during the confirmatory trial.
Who cannot join
- Have experienced intolerable adverse reactions (as defined in Attachment 3) during the confirmatory trial.
- Have met any of the exclusion criteria applicable at the time of giving written informed consent, those applicable at the time of randomization, or subject withdrawal criteria in the confirmatory trial.
- Serious respiratory dysfunction.
- Asthma.
- Serious bradyarrhythmia.
- Serious hepatic dysfunction.
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- Serious renal dysfunction.
- Susceptibility to respiratory depression due to conditions such as increased intracranial pressure, head injury and brain tumor.
- Patients who have a history of clinically significant adverse reactions to the combination of opioid analgesics and any of the following drugs/substances, and who are currently receiving or expect to receive any of them during the study:
- Central nervous system depressants (phenothiazines, benzodiazepines and barbiturates), inhalation anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, skeletal muscle relaxants, antihistamines, ritonavir, alcohol, itraconazole, amiodarone, clarithromycin, diltiazem, and fluvoxamine.
- History of convulsive seizures (except a single episode of infantile febrile convulsions).
- History of hypersensitivity to fentanyl.
- Pregnant or lactating women, possibly pregnant women, or women who are planning to become pregnant.
- Patients who are judged by the investigator/subinvestigator to be inappropriate for this study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Azumino, Nagano
Study site
Bunkyo-ku, Tokyo
Study site
Ibaraki, Osaka
Study site
Izumisano, Osaka
Study site
Kanazawa, Ishikawa-ken
Study site
Kasama, Ibaraki
Study site
Katori-shi, Chiba
Study site
Kitakyushu, Fukuoka
Study site
Kōriyama, Fukushima
Study site
Kumamoto
Study site
Matsuyama, Ehime
Study site
Mibu, Tochigi
Study site
Nagoya, Aichi-ken
Study site
Nishinomiya, Hyōgo
Study site
Okayama
Study site
Sapporo, Hokkaido
Study site
Shinagawa-ku, Tokyo
Study site
Toyama
Study site
Uji, Kyoto
Study site
Wakayama
About this study
Official title: A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
- Conditions
- Pain, Cancer
- Being tested
- KW-2246 (fentanyl citrate)
- Keywords
- Pain, Cancer
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-2246 (fentanyl citrate)Drug
KW-2246 (fentanyl citrate)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | KW-2246 (fentanyl citrate) Receives: Drug: KW-2246 (fentanyl citrate) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
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
- NCT00683995
- Sponsor's protocol ID
- 2246-0703
- Status last verified
- Aug 2020
- First submitted
- 22 May 2008
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT00683995
- Acronym / sponsor ID
- 2246-0703
- Conditions
- Pain, Cancer
- Keywords
- Pain, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 May 2008 (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 designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
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 (7 listed)
- Provide written informed consent to participate in the study on a voluntary basis.
- Patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial.
- Outpatients who live with a caregiver such as a family member, or inpatients.
- Require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator.
- Performance Status (ECOG) of 3 or less at the time of giving written informed consent.
Key exclusion criteria (14 listed)
- Have experienced intolerable adverse reactions (as defined in Attachment 3) during the confirmatory trial.
- Have met any of the exclusion criteria applicable at the time of giving written informed consent, those applicable at the time of randomization, or subject withdrawal criteria in the confirmatory trial.
- Serious respiratory dysfunction.
- Asthma.
- Serious bradyarrhythmia.
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)KW-2246 (fentanyl citrate) | Drug | 1 |
Primary outcome
Not reported in the source record.
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 28 Aug 2020.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KW-2246 (fentanyl citrate) in people with Pain, Cancer, run by Kyowa Kirin Co., Ltd. at 20 sites 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 7 inclusion and 14 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 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.
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 28 Aug 2020.