Cancer Related Pain (Breakthrough Pain)Phase 32246-004NCT01326689
A Comparative Study of KW-2246
A Phase 3 study testing KW-2246 in people with Cancer Related Pain (Breakthrough Pain), run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer Related Pain (Breakthrough Pain)
- What is being tested?
- KW-2246
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2011to Jun 2012
- 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
- Written informed consent
- Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
- Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
- ECOG PS =< 3
Who cannot join
- Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
- Severe respiratory dysfunction
- Asthma
- Severe bradyarrhythmia
- Severe hepatic function disorder
- Severe renal function disorder
- Severe psychoneurotic disorder
- Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.
- Conditions
- Cancer Related Pain (Breakthrough Pain)
- Being tested
- KW-2246, Placebo
- Medical subject headings
- Cancer Pain, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-2246Drug
Rescue medication at an optimal dose, which is determined by dose titration
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KW-2246 | Experimental | Not described Receives: Drug: KW-2246 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity difference
Pain scores on the visual analog scale
Measured: 30 minutes after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Related Pain (Breakthrough 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326689
- Sponsor's protocol ID
- 2246-004
- Acronym
- 2246-004
- Status last verified
- Mar 2017
- First submitted
- 30 Mar 2011
- Last updated
- 8 Mar 2017
- Results posted
- No
Publications
Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.
PubMed 24839047
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
- ClinicalTrials.gov ID
- NCT01326689
- Acronym / sponsor ID
- 2246-004 / 2246-004
- Conditions
- Cancer Related Pain (Breakthrough Pain)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Mar 2011 (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 is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KW-2246 | Experimental | Drug: KW-2246 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
- Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
- ECOG PS =< 3
Key exclusion criteria (8 listed)
- Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
- Severe respiratory dysfunction
- Asthma
- Severe bradyarrhythmia
- Severe hepatic function disorder
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-2246Rescue medication at an optimal dose, which is determined by dose titration | Drug | KW-2246 |
| Placebo | Drug | Placebo |
Primary outcome
Pain intensity difference
Time frame: 30 minutes after each dose
Pain scores on the visual analog scale
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 8 Mar 2017.
- Derived from this study: PubMed 24839047Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Cancer Related Pain (Breakthrough Pain), 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 4 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 8 Mar 2017. 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. Some participants in this study may receive a placebo. 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 difference (time frame: 30 minutes after each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326689, which also lists 1 linked publication.
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 8 Mar 2017.