Phase 4
Completed N=66
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.
Source: ClinicalTrials.gov NCT02660229 ↗Enrolled (actual)
66
Serious AEs
7.6%
Results posted
Nov 2018
Primary outcomePrimary: Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. — -3.52; -3.13 units on a scale
◆ Published Evidence
Emerging
19citations · ~2 / year
Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study.
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.
Linked Publications
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Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. |
-3.52; -3.13 | — |
| SECONDARY Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration |
226.80; 226.64 | — |
| SECONDARY Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization |
9; 8; 10; 10; 12; 12 | — |
| SECONDARY Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization |
10; 9; 16; 15; 5; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult men and women aged 19 years or more
- Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
- Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
- Subjects who voluntarily signed the Informed Consent Form for the study
- Subjects who are capable of understanding details of the study and verbal communication on pain intensity
Exclusion Criteria
- 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)
- Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
- Patients who have contraindications and cautions when study drugs administered.
Data sourced from ClinicalTrials.gov (NCT02660229) and the linked publication. 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.