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KW-2246 (Abstral) Switching Study in Cancer Pain

NCT00355628Phase 2

Key facts

Status: Completed
Start: Jul 2006
Primary completion: Jul 2007
Countries: 1
Sponsor: Kyowa Kirin
Modality: Orthosteric Ligands

Drugs: fentanyl
Conditions: cancer pain

Overview

Phase 2, open-label, single-arm trial of fentanyl in cancer pain, sponsored by Kyowa Kirin. Primary endpoints: Safety and Tolerability and Pain Intensity as Rated on a Categorical Scale. Started Jul 2006; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

KW-2246
Patients switch from oral opioids to KW-2246

Who it enrols

Patients with cancer pain maintained on oral morphine or oxycodone (20-120 mg/day) without rescue doses, excluding those with serious respiratory, hepatic, or renal dysfunction.

Endpoints

Primary

Safety and TolerabilityAt every visit
Pain Intensity as Rated on a Categorical ScaleAt specified visits

Secondary

Pain Intensity as Rated on a Visual Analog Scale (VAS)At specified visits
Number of Rescue Doses per DayAt every visit
Regular Dose Level of KW-2246At every visit

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