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

This study has been completed.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd Identifier:
First received: March 30, 2011
Last updated: March 6, 2017
Last verified: March 2017
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 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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)

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Pain intensity difference [ Time Frame: 30 minutes after each dose ]
    Pain scores on the visual analog scale

Enrollment: 42
Study Start Date: March 2011
Study Completion Date: June 2012
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
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01326689

Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01326689     History of Changes
Other Study ID Numbers: 2246-004
Study First Received: March 30, 2011
Last Updated: March 6, 2017

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on August 18, 2017