A Comparative Study of KW-2246

Cancer Related Pain (Breakthrough Pain) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326689
• Other study ID #: 2246-004
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2011
• Last updated: March 6, 2017
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer Related Pain (Breakthrough Pain)

Intervention

Drug:
• KW-2246
Rescue medication at an optimal dose, which is determined by dose titration
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity difference	Pain scores on the visual analog scale	30 minutes after each dose