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Completed

NCT Number: 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.

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone hydrochloride

Drug

Oxycodone injection

Other names: Oxynorm

Morphine sulphate

Drug

Morphine sulphate injection

Other names: BC morphine

Primary outcomes

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

    Time frame: 5 days

    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.

Secondary outcomes

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

    Time frame: 5 days

    The dose of the study drugs intravenously administered was checked and recorded every day. The information on the dose administered from baseline to each assessment time point was collected based on records on the chart, and in the event of dose change/end of treatment, pertinent date and time, and dose were recorded accurately on the chart.

    ‡ Total administered dose of the study drugs (mg)= IV infusion (mg/hr) * [(End date - start date) * 24 + (end time - start time)] + bolus injection (mg)

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

    Time frame: 5 days

    The subjects made an assessment of overall treatment satisfaction regarding pain using the PGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse) after baseline and at the end of the study (Day 5).

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

    Time frame: 5 days

    The investigators made an assessment using the CGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse).

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study 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

Acronym: SWITCH

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2016
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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