Clinical trial NCT02660229: An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.
Official title: A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer Pain
Keywords: Intravenous injection in cancer pain
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2016-01-21
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

Detailed description: 5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

Eligibility criteria: Inclusion Criteria:

1. Adult men and women aged 19 years or more
2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
3. Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
4. Subjects who voluntarily signed the Informed Consent Form for the study
5. Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

1. Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
3. Patients who have contraindications and cautions when study drugs administered.

Primary outcomes:
measure: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
timeFrame: 5 days
Secondary outcomes:
measure: Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
timeFrame: 5 days
measure: Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
timeFrame: 5 days
measure: Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
timeFrame: 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Jinhyong Kang, Dr. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee KH, Kang JH, Oh HS, Choi MK, Shim BY, Eum YJ, Park HJ, Kang JH. Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study. Pain Res Manag. 2017;2017:9741729. doi: 10.1155/2017/9741729. Epub 2017 Oct 31.