A Phase III Clinical Study of KW-2246
1 other identifier
interventional
43
1 country
20
Brief Summary
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2008
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedAugust 28, 2020
August 1, 2020
1.3 years
May 22, 2008
August 27, 2020
Conditions
Keywords
Study Arms (1)
1
EXPERIMENTALKW-2246 (fentanyl citrate)
Interventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent to participate in the study on a voluntary basis.
- 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.
You may not qualify if:
- Have experienced intolerable adverse reactions (as defined in Attachment 3) during 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Katori-shi, Chiba, Japan
Unknown Facility
Matsuyama, Ehime, Japan
Unknown Facility
Kitakyushu, Fukuoka, Japan
Unknown Facility
Kōriyama, Fukushima, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Nishinomiya, Hyōgo, Japan
Unknown Facility
Kasama, Ibaraki, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, Japan
Unknown Facility
Uji, Kyoto, Japan
Unknown Facility
Azumino, Nagano, Japan
Unknown Facility
Ibaraki, Osaka, Japan
Unknown Facility
Izumisano, Osaka, Japan
Unknown Facility
Mibu, Tochigi, Japan
Unknown Facility
Bunkyo-ku, Tokyo, Japan
Unknown Facility
Shinagawa-ku, Tokyo, Japan
Unknown Facility
Kumamoto, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Wakayama, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Kyowa Kirin Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 26, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2009
Study Completion
October 1, 2011
Last Updated
August 28, 2020
Record last verified: 2020-08