An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Tapentadol

Criteria

Inclusion Criteria:

• Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent

• Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent

• Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent

• Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator

• Participants who are able to visit the medical institutions throughout the study period

Exclusion Criteria:

• Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent

• Participants with current or a history of epilepsy or seizure disorders

• Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)

• Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)

• Participants with moderate to severe liver dysfunction or severe renal dysfunction