Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Collaborator: Grünenthal GmbH
• Treatments: Analgesics, Opioid; Tapentadol

Criteria

Inclusion Criteria:

• Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations [120 milligram per day {mg/day} or less], oxycodone hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain control with opioid therapy

• Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics [drug used to control pain])

• Definite diagnosis of any type of cancer, which has been notified to the participant

• Participants who can be hospitalized during the treatment period

• Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study

Exclusion Criteria:

• Participants with bradyarrhythmia (slow, irregular heartbeats)

• History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue [usually because of decreased blood flow]) attack within 1 year before informed consent

• Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness

• Previous or concurrent alcohol dependence or narcotic abuse

• History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent