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Completed

NCT Number: NCT01326689

A Comparative Study of KW-2246

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.

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Key information

Conditions

Cancer Related Pain (Breakthrough Pain) Breakthrough Pain Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KW-2246

Drug

Rescue medication at an optimal dose, which is determined by dose titration

Placebo

Drug

Primary outcomes

  1. Pain intensity difference

    Time frame: 30 minutes after each dose

    Pain scores on the visual analog scale

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)

Acronym: 2246-004

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 31, 2011
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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