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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326689
First Posted: March 31, 2011
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  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 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326689


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01326689     History of Changes
Other Study ID Numbers: 2246-004
First Submitted: March 30, 2011
First Posted: March 31, 2011
Last Update Posted: March 8, 2017
Last Verified: March 2017

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