A Phase III Clinical Study of KW-2246

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00683995
First received: May 22, 2008
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Pain, Cancer
Drug: KW-2246 (fentanyl citrate)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Enrollment: 43
Study Start Date: March 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KW-2246 (fentanyl citrate)
Drug: KW-2246 (fentanyl citrate)
KW-2246 (fentanyl citrate)
Other Name: KW-2246 (fentanyl citrate)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683995

Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00683995     History of Changes
Other Study ID Numbers: 2246-0703
Study First Received: May 22, 2008
Last Updated: August 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Pain, Cancer

Additional relevant MeSH terms:
Citric Acid
Fentanyl
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 19, 2014