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.

NCT02660229 | Completed Phase 4 Results

• 1 other identifier: OXI15-KR-401
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Keywords

Intravenous injection in cancer pain

Outcome Measures

Primary Outcomes (1)

• Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.

  For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5. Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain.

  5 days

Secondary Outcomes (3)

• Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration

  5 days

• Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization

  5 days

• Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization

  5 days

Study Arms (2)

Oxycodone Hydrochloride

EXPERIMENTAL

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Drug: Oxycodone Hydrochloride

Morphine Sulphate

ACTIVE COMPARATOR

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Drug: Morphine Sulphate

Interventions

Oxycodone Hydrochloride DRUG

Oxycodone injection

Also known as: Oxynorm

Oxycodone Hydrochloride

Morphine Sulphate DRUG

Morphine sulphate injection

Also known as: BC morphine

Morphine Sulphate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29670416 DERIVED

MeSH Terms

Conditions

Cancer Pain

Interventions

Oxycodone; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Mrs Suyoun Yang/CR head
• Organization: Mundipharma Korea Ltd.

suyoun.yang@mundipharma.co.kr

82-2-527-9219

Study Officials

• Jinhyong Kang, Dr. Ph.D

  Seoul St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)