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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Cancer Pain
Interventions Drug: Oxycodone Hydrochloride
Drug: Morphine Sulphate
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection. The 10mg/1ml or 20mg/2ml was injected through intravenous PCA according to patient's pain intensity

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection. The 5mg/5ml or 30mg/2ml was injected through intravenous PCA according to patient's pain intensity.

Period Title: Overall Study
Started 34 [1] 32 [1]
Safety Analysis Set 34 32
FAS Set 33 [2] 32
Per Protocol Set 28 [3] 29 [4]
Completed 32 31
Not Completed 2 1
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             0             1
[1]
Randomization
[2]
Oxycodone group: 1 patient was missed any efficacy assessment.
[3]
Adverse events N=1, Prohibited medication N=4
[4]
Withdrawal of ICF N=1, IC/EC deviation N=1, Prohibited medication N=1
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate Total
Hide Arm/Group Description

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone IV injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate IV injection

Total of all reporting groups
Overall Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
Demographic data was analysed FAS set.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
<39 years 0 2 2
40-49 years 1 2 3
50-59 years 5 6 11
60-69 years 27 22 49
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
12
  36.4%
10
  31.3%
22
  33.8%
Male
21
  63.6%
22
  68.8%
43
  66.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 33 participants 32 participants 65 participants
33 32 65
1.Primary Outcome
Title Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
Hide Description

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.

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Primary endpoint was analysed FAS set.
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description:

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.52  (2.17) -3.13  (1.84)
2.Secondary Outcome
Title Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
Hide Description

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)

Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS set.
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description:

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: mg
226.80  (110.44) 226.64  (135.13)
3.Secondary Outcome
Title Patient’s Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
Hide Description 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).
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline. So, missing data was excluded from analysis. Oxynorm group 32 subjects and Morphine group 31 subjects were analysed for PGIC.
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description:

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Overall Number of Participants Analyzed 32 31
Measure Type: Count of Participants
Unit of Measure: Participants
1:Very much improved
9
  28.1%
8
  25.8%
2: Much Improved
10
  31.3%
10
  32.3%
3: Minimally improved
12
  37.5%
12
  38.7%
4: No change
1
   3.1%
1
   3.2%
5: Minimally worse
0
   0.0%
0
   0.0%
6: Much worse
0
   0.0%
0
   0.0%
7: Very much worse
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Investigator’s Overall Satisfaction With IV Infusion on 5 Days After Randomization
Hide Description 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).
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description

FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline.

So, the data was missed.

Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description:

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

Overall Number of Participants Analyzed 32 31
Measure Type: Count of Participants
Unit of Measure: Participants
1: Very much improved
10
  31.3%
9
  29.0%
2: Much improved
16
  50.0%
15
  48.4%
3: Minimal improved
5
  15.6%
6
  19.4%
4. No change
1
   3.1%
1
   3.2%
5. Minimally worse
0
   0.0%
0
   0.0%
6. Much worse
0
   0.0%
0
   0.0%
7. Very much worse
0
   0.0%
0
   0.0%
Time Frame 5 days
Adverse Event Reporting Description The safety analysis was performed regarding AEs, vital signs, physical examination, clinical laboratory test, and ECG in the Safety set involving all subjects who received the study drug after randomization in this clinical study.
 
Arm/Group Title Oxycodone Hydrochloride Morphine Sulphate
Hide Arm/Group Description

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Morphine Sulphate: Morphine sulphate injection

All-Cause Mortality
Oxycodone Hydrochloride Morphine Sulphate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oxycodone Hydrochloride Morphine Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/34 (8.82%)      2/32 (6.25%)    
Blood and lymphatic system disorders     
Neutropenia  1  1/34 (2.94%)  1 1/32 (3.13%)  1
General disorders     
Pyrexia  1  1/34 (2.94%)  1 0/32 (0.00%)  0
Investigations     
Platelet count decreased  1  1/34 (2.94%)  1 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/34 (0.00%)  0 1/32 (3.13%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxycodone Hydrochloride Morphine Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/34 (41.18%)      11/32 (34.38%)    
Gastrointestinal disorders     
Nausea  1 [1]  4/34 (11.76%)  4 5/32 (15.63%)  5
Constipation  1 [1]  7/34 (20.59%)  7 3/32 (9.38%)  3
Vomiting  1 [1]  0/34 (0.00%)  0 1/32 (3.13%)  1
Dyspepsia  1 [1]  1/34 (2.94%)  1 0/32 (0.00%)  0
General disorders     
Asthenia  1 [1]  0/34 (0.00%)  0 1/32 (3.13%)  1
Nervous system disorders     
Dizziness  1 [1]  2/34 (5.88%)  2 3/32 (9.38%)  3
Somnolence  1 [1]  3/34 (8.82%)  3 1/32 (3.13%)  1
Sedation  1 [1]  1/34 (2.94%)  1 0/32 (0.00%)  0
Renal and urinary disorders     
Dysuria  1 [1]  0/34 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders     
Pruritus generalised  1 [1]  0/34 (0.00%)  0 1/32 (3.13%)  1
Hyperhidrosis  1 [1]  1/34 (2.94%)  1 1/32 (3.13%)  1
Vascular disorders     
Hypotension  1 [1]  1/34 (2.94%)  1 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
[1]
Adverse drug reaction
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mrs Suyoun Yang/CR head
Organization: Mundipharma Korea Ltd.
Phone: 82-2-527-9219
Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT02660229     History of Changes
Other Study ID Numbers: OXI15-KR-401
First Submitted: January 18, 2016
First Posted: January 21, 2016
Results First Submitted: May 18, 2017
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018