Phase 3
Completed N=340
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
Source: ClinicalTrials.gov NCT01165281 ↗Enrolled (actual)
340
Serious AEs
43.2%
Results posted
Jan 2014
Primary outcomePrimary: Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale — -2.69; -2.57 Scores on scale — p=0.786
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale |
-2.69; -2.57 | 0.786 |
| SECONDARY Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories |
58.7; 50.4; 4.0; 1.4 | — |
| SECONDARY Frequency of Rescue Medication Use for the Double-blind Treatment Period |
1.39; 1.35 | — |
| SECONDARY Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period |
6.95; 6.73 | — |
| SECONDARY Proportion of Patients With Various Levels of Pain Improvement (Responders) |
63.5; 59.0; 50.0; 42.4 | — |
| SECONDARY Proportion of Patients Entering the Maintenance Period |
86; 80 | — |
| SECONDARY Number of Patients Who Discontinued Due to Lack of Efficacy |
1; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01165281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.