A Comparative Study of KW-2246 (2246-004)

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Cancer Related Pain (Breakthrough Pain)

Treatments: Drug: KW-2246; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326689

2246-004

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

KW-2246

Experimental group

Treatment:

Drug: KW-2246

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo