A Phase III Clinical Study of KW-2246 (NCT00683995) | Clinical Trial Compass
CompletedPhase 3
A Phase III Clinical Study of KW-2246
Japan43 participantsStarted 2008-03
Plain-language summary
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Serious renal dysfunction.
* Susceptibility to respiratory depression due to conditions such as increased intracranial pressure, head injury and brain tumor.
* Patients wh…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.