A Comparative Study of KW-2246
2246-004
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 8, 2017
March 1, 2017
1.3 years
March 30, 2011
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity difference
Pain scores on the visual analog scale
30 minutes after each dose
Study Arms (2)
KW-2246
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
Related Publications (1)
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.
PMID: 24839047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
March 31, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 8, 2017
Record last verified: 2017-03