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
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

ClinicalTrials.gov processed this record on April 21, 2014