A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Documented clinical diagnosis of any type of cancer

• Diagnosis of chronic malignant tumor-related cancer pain with an average score for pain intensity in the past 24 hours of >=4 on the 11-point numerical rating scale (NRS) on the day of randomization (Day -1)

• Have not received treatment with opioid analgesics within 28 days before screening (Note: codeine phosphate [<=60 mg/d] or dihydrocodeine phosphate [<=30 mg/d] for antitussive use are allowed)

• Dissatisfied with pain relief by the current treatment and for whom the investigator or designee judges that treatment with opioid analgesics is required

Exclusion Criteria:

• Have complicated with uncontrolled/clinically significant arrhythmia

• Have previous or concurrent presence of any disease which may develop increased intracranial pressure, disturbance of consciousness, lethargy, or respiratory problems such as traumatic encephalopathy with cerebral contusion, intracranial hematoma, disturbance of consciousness, brain tumor, cerebral infarction, transient ischemic attack, epilepsy or convulsive diseases

• Have history of alcohol and/or drug abuse

• Have any disease for which opioids are contraindicated such as serious respiratory depression of serious chronic obstructive pulmonary disease, bronchial asthma attack, cardiac failure secondary to chronic pulmonary disease, paralytic ileus, status epileptics, tetanus, strychnine poisoning, acute alcohol poisoning, hypersensitivity to opium alkaloid, hemorrhagic colitis, or bacterial diarrhea