A Comparative Study of KW-2246 (2246-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01326689
First received: March 30, 2011
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.


Condition Intervention Phase
Cancer Related Pain (Breakthrough Pain)
Drug: KW-2246
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain intensity difference [ Designated as safety issue: No ]
    Pain scores on the visual analog scale


Study Start Date: March 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-2246 Drug: KW-2246
Rescue medication at an optimal dose, which is determined by dose titration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
  • Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
  • ECOG PS =< 3

Exclusion Criteria:

  • Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
  • Severe respiratory dysfunction
  • Asthma
  • Severe bradyarrhythmia
  • Severe hepatic function disorder
  • Severe renal function disorder
  • Severe psychoneurotic disorder
  • Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
  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: NCT01326689

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01326689     History of Changes
Other Study ID Numbers: 2246-004
Study First Received: March 30, 2011
Last Updated: November 6, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014