- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683995
A Phase III Clinical Study of KW-2246
August 27, 2020 updated by: Kyowa Kirin Co., Ltd.
A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients
This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.
Study Overview
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kumamoto, Japan
-
Okayama, Japan
-
Toyama, Japan
-
Wakayama, Japan
-
-
Aichi
-
Nagoya, Aichi, Japan
-
-
Chiba
-
Katori, Chiba, Japan
-
-
Ehime
-
Matsuyama, Ehime, Japan
-
-
Fukuoka
-
Kitakyushu, Fukuoka, Japan
-
-
Fukushima
-
Koriyama, Fukushima, Japan
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan
-
-
Hyogo
-
Nishinomiya, Hyogo, Japan
-
-
Ibaraki
-
Kasama, Ibaraki, Japan
-
-
Ishikawa
-
Kanazawa, Ishikawa, Japan
-
-
Kyoto
-
Uji, Kyoto, Japan
-
-
Nagano
-
Azumino, Nagano, Japan
-
-
Osaka
-
Ibaraki, Osaka, Japan
-
Izumisano, Osaka, Japan
-
-
Tochigi
-
Mibu, Tochigi, Japan
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan
-
Shinagawa-ku, Tokyo, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
KW-2246 (fentanyl citrate)
|
KW-2246 (fentanyl citrate)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 22, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 26, 2008
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2246-0703
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Cancer
-
Kyowa Kirin Co., Ltd.Completed
-
University Hospital, Basel, SwitzerlandTerminatedCancer: Breakthrough Pain | Cancer: Extreme Pain on MovementSwitzerland
-
University of UtahCompletedCancer-associated PainUnited States
-
University of JordanCompleted
-
Laboratoires Bouchara-RecordatiUnknown
-
University of PittsburghCompletedMetastatic Cancer | Invasive Cancer | Pain, CancerUnited States
-
Wex Pharmaceuticals Inc.Completed
-
Sorrento Therapeutics, Inc.WithdrawnPain, Intractable | Pain Cancer
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on KW-2246 (fentanyl citrate)
-
Kyowa Kirin Co., Ltd.Completed
-
Kyowa Kirin Co., Ltd.Completed
-
Kyowa Kirin Co., Ltd.Completed
-
Samuel Lunenfeld Research Institute, Mount Sinai...Terminated
-
Nationwide Children's HospitalCompletedTetralogy of Fallot (TOF) | Ventricular Septal Defects (VSD) | Atrioventricular Septal Defects (AVSD)United States
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
INSYS Therapeutics IncCompleted
-
Beni-Suef UniversityUnknown
-
Archimedes Development LtdCompleted
-
Lung Biotechnology PBCTerminatedPulmonary Arterial HypertensionUnited States, Israel