Clinical trial NCT00683995: A Phase III Clinical Study of KW-2246
Official title: A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Cancer
Keywords: Pain, Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.


Eligibility criteria: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Katori
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Kitakyushu
country: Japan
state: Fukuoka
city: Koriyama
country: Japan
state: Fukushima
city: Sapporo
country: Japan
state: Hokkaido
city: Nishinomiya
country: Japan
state: Hyogo
city: Kasama
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Uji
country: Japan
state: Kyoto
city: Azumino
country: Japan
state: Nagano
city: Ibaraki
country: Japan
state: Osaka
city: Izumisano
country: Japan
state: Osaka
city: Mibu
country: Japan
state: Tochigi
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Kumamoto
country: Japan
city: Okayama
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Study Director
role: STUDY_DIRECTOR
References: