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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. (SWITCH)

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ClinicalTrials.gov Identifier: NCT02660229
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Oxycodone Hydrochloride Drug: Morphine Sulphate Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxycodone Hydrochloride
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Drug: Oxycodone Hydrochloride
Oxycodone injection
Other Name: Oxynorm

Active Comparator: Morphine Sulphate
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Drug: Morphine Sulphate
Morphine sulphate injection
Other Name: BC morphine




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660229


Locations
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Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Mundipharma Korea Ltd
Investigators
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Principal Investigator: Jinhyong Kang, Dr. Ph.D Seoul St. Mary's Hospital, The Catholic University of Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT02660229     History of Changes
Other Study ID Numbers: OXI15-KR-401
First Posted: January 21, 2016    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mundipharma Korea Ltd:
Intravenous injection in cancer pain

Additional relevant MeSH terms:
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Oxycodone
Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents