CompletedNCT013266892246-004Updated Mar 8, 2017

A Comparative Study of KW-2246

A Phase 3 interventional study of KW-2246 and Placebo in Cancer Related Pain (Breakthrough Pain), sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Cancer Related Pain (Breakthrough Pain)

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Who can participate

Ages eligible: 20 Years and older
Sexes eligible: 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 42 participants (actual)

Study arms

Experimental
KW-2246
Drug: KW-2246
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugKW-2246
Rescue medication at an optimal dose, which is determined by dose titration
DrugPlacebo

What researchers measure

Primary outcomes

Pain intensity difference
Pain scores on the visual analog scale
Time frame: 30 minutes after each dose

Study locations

1 site

Tokyo, Japan

References and documents

Publications

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. PubMed 24839047 ↗

Registry details

Key details

Study ID: NCT01326689
Lead sponsor: Kyowa Kirin Co., Ltd.
Responsible party: Sponsor
First posted: Mar 31, 2011
Start date: Mar 2011
Primary completion: Jun 2012
Completion: Jun 2012
Last update: Mar 8, 2017

View the source record on ClinicalTrials.gov ↗

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