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

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Oxycodone CR (Drug); R331333 (referred to as JNS024 ER or CG5503) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

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.

Clinical Details

Official title: A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories

Frequency of Rescue Medication Use for the Double-blind Treatment Period

Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period

Proportion of Patients With Various Levels of Pain Improvement (Responders)

Proportion of Patients Entering the Maintenance Period

Number of Patients Who Discontinued Due to Lack of Efficacy

Detailed description: This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study staff will know the identity of the study drug assigned to each patient), multicenter study to evaluate the safety and efficacy of orally (by mouth) administered R331333 (referred to as JNS024 extended release [ER] capsules or CG5503) in dosages of 25 mg to 200 mg twice daily compared with orally administered capsules of oxycodone controlled release (CR) in dosages of 5 mg to 40 mg twice daily over 4 weeks in Japanese and Korean patients with moderate to severe chronic malignant tumor-related cancer pain who require around-the-clock opioid therapy (treatment with narcotic analgesics or pain relievers) and are dissatisfied with the pain relief they are experiencing from current treatment. The active control, oxycodone CR, is being used in this study because it is an opioid analgesic approved for the treatment of moderate to severe pain. Approximately 212 Japanese patients and approximately 100 Korean patients who meet screening criteria for the study will be enrolled in the study and will enter the titration period of the study where they will receive a starting dosage of either JNS024 ER 25 mg twice daily or oxycodone CR 5 mg twice daily. The dose of study drug for each patient will be titrated (increased) to the optimal dose until sufficient analgesia (pain relief) is achieved (ie, up to a maximum dose of JNS024 ER 200 mg twice daily or Oxycodone CR 40 mg twice daily). When the dosage of study drug is increased, the safety will be confirmed at the study visit or by telephone on the day after the dose is increased. Once an optimal dose of study drug is determined, the patient will continue to receive that dose during the maintenance period in the study. Patients will participate in the study for total of approximately 6 weeks; during this time patients will receive study drug for 4 weeks (titration and maintenance periods combined). During the study, if a patient experiences breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) will be given. In addition, patients will be allowed to continue to take stable doses of non-opioid analgesics (non-narcotic pain medications for mild to moderate pain) that they were taking at the time of study entry and may reduce the dosage or discontinue their use during the study. During the study, blood samples will be collected from patients at protocol-specified time points to determine the concentration of study drug after administration. The safety of patients will be monitored during the study by evaluating adverse events and findings from clinical laboratory tests, physical examinations, vital signs measurements, and electrocardiogram (ECG) measurements reported. The primary outcome measure in the study will be the change from baseline to the last 3 days of study drug administration in the average pain intensity score using an 11 point numerical rating scale (NRS). Patients will receive R331333 (referred to as JNS024 ER or CG5503) by mouth with or without food at a starting dose of 25 mg twice daily to be increased if necessary to a maximum dose of 200 mg twice daily for a total of 4 weeks (titration and maintenance periods combined) OR double-blind oxycodone CR by mouth with or without food at a starting dose of 5 mg twice daily to be increased if necessary to a maximum dose of 40 mg twice daily for a total of 4 weeks.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Chiba, Japan

Fukui, Japan

Fukushima, Japan

Fukuyama, Japan

Fushimi, Japan

Hamamatsu, Japan

Hirosaki, Japan

Hitachi, Japan

Itami, Japan

Iwakuni, Japan

Izumo, Japan

Kamogawa, Japan

Kanuma, Japan

Kobe, Japan

Kumagaya, Japan

Kumamoto, Japan

Kure, Japan

Kyoto, Japan

Matsumoto, Japan

Matsusaka, Japan

Miyazaki, Japan

Nagoya, Japan

Natori, Japan

Niigata, Japan

Ogori, Japan

Ohta, Japan

Okayama, Japan

Osaka, Japan

Saga, Japan

Saku, Japan

Sapporo, Japan

Sendai, Japan

Sunto, Japan

Takarazuka, Japan

Takasaki, Japan

Tokyo, Japan

Tomakomai, Japan

Toyama, Japan

Toyonaka, Japan

Ube, Japan

Yamagata, Japan

Yamanashi, Japan

Yokohama, Japan

Busan, Korea, Republic of

Chungcheongbuk-Do, Korea, Republic of

Dae-Gu, Korea, Republic of

Daegu, Korea, Republic of

Deajun, Korea, Republic of

Gyeonggi-Do, Korea, Republic of

Incheon, Korea, Republic of

Jinju-Si, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Additional Information

Starting date: August 2010
Last updated: December 13, 2013

Page last updated: August 23, 2015

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