Status:
COMPLETED
Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants
Lead Sponsor:
Janssen Pharmaceutical K.K.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Pain
Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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; ex...
Detailed Description
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in J...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00805142
Start Date
November 1 2008
End Date
July 1 2009
Last Update
July 29 2013
Active Locations (21)
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1
Chiba, Japan
2
Chikushino-shi, Japan
3
Fukuoka, Japan
4
Himeji, Japan