A Comparative Study of KW-2246

Kyowa Kirin Co., Ltd.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cancer Related Pain (Breakthrough Pain)

Interventions

KW-2246DRUG

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

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Pain intensity difference

Pain scores on the visual analog scale

Time frame: 30 minutes after each dose

Data from ClinicalTrials.gov

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