A Phase III Clinical Study of KW-2246

NCT ID: NCT00683995

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

KW-2246 (fentanyl citrate)

Group Type: EXPERIMENTAL

KW-2246 (fentanyl citrate)

Intervention Type: DRUG

KW-2246 (fentanyl citrate)

Interventions

KW-2246 (fentanyl citrate)

KW-2246 (fentanyl citrate)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

Nagoya, Aichi-ken, Japan

Katori-shi, Chiba, Japan

Matsuyama, Ehime, Japan

Kitakyushu, Fukuoka, Japan

Kōriyama, Fukushima, Japan

Sapporo, Hokkaido, Japan

Nishinomiya, Hyōgo, Japan

Kasama, Ibaraki, Japan

Kanazawa, Ishikawa-ken, Japan

Uji, Kyoto, Japan

Azumino, Nagano, Japan

Ibaraki, Osaka, Japan

Izumisano, Osaka, Japan

Mibu, Tochigi, Japan

Bunkyo-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Kumamoto, , Japan

Okayama, , Japan

Toyama, , Japan

Wakayama, , Japan

Countries

Japan

Other Identifiers

2246-0703

Identifier Type: -

Identifier Source: org_study_id