Back to resultsA Comparative Study of KW-2246 (2246-004)
Primary Purpose
Cancer Related Pain (Breakthrough Pain)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KW-2246
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Related Pain (Breakthrough Pain)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KW-2246
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity difference
Pain scores on the visual analog scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326689
Brief Title
A Comparative Study of KW-2246
Acronym
2246-004
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Pain (Breakthrough Pain)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KW-2246
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KW-2246
Intervention Description
Rescue medication at an optimal dose, which is determined by dose titration
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain intensity difference
Description
Pain scores on the visual analog scale
Time Frame
30 minutes after each dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24839047
Citation
Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.
Results Reference
derived
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A Comparative Study of KW-2246
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