Trial Outcomes & Findings for 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. (NCT NCT02660229)
NCT ID: NCT02660229
Last Updated: 2018-11-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
5 days
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Oxycodone Hydrochloride
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
|
Morphine Sulphate
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
Safety Analysis Set
|
34
|
32
|
|
Overall Study
FAS Set
|
33
|
32
|
|
Overall Study
Per Protocol Set
|
28
|
29
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Oxycodone Hydrochloride
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
|
Morphine Sulphate
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Oxycodone Hydrochloride
n=33 Participants
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone IV injection
|
Morphine Sulphate
n=32 Participants
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate IV injection
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<39 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Primary endpoint was analysed FAS set.
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.
Outcome measures
| Measure |
Oxycodone Hydrochloride
n=33 Participants
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=32 Participants
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
|
-3.52 units on a scale
Standard Deviation 2.17
|
-3.13 units on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 5 daysPopulation: FAS set.
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)
Outcome measures
| Measure |
Oxycodone Hydrochloride
n=33 Participants
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=32 Participants
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
|
226.80 mg
Standard Deviation 110.44
|
226.64 mg
Standard Deviation 135.13
|
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
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).
Outcome measures
| Measure |
Oxycodone Hydrochloride
n=32 Participants
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=31 Participants
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
1:Very much improved
|
9 Participants
|
8 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
2: Much Improved
|
10 Participants
|
10 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
3: Minimally improved
|
12 Participants
|
12 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
4: No change
|
1 Participants
|
1 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
5: Minimally worse
|
0 Participants
|
0 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
6: Much worse
|
0 Participants
|
0 Participants
|
|
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
7: Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
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).
Outcome measures
| Measure |
Oxycodone Hydrochloride
n=32 Participants
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=31 Participants
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
1: Very much improved
|
10 Participants
|
9 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
2: Much improved
|
16 Participants
|
15 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
3: Minimal improved
|
5 Participants
|
6 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
4. No change
|
1 Participants
|
1 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
5. Minimally worse
|
0 Participants
|
0 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
6. Much worse
|
0 Participants
|
0 Participants
|
|
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
7. Very much worse
|
0 Participants
|
0 Participants
|
Adverse Events
Oxycodone Hydrochloride
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Morphine Sulphate
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxycodone Hydrochloride
n=34 participants at risk
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=32 participants at risk
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
General disorders
Pyrexia
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
0.00%
0/32 • 5 days
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/34 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Investigations
Platelet count decreased
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
0.00%
0/32 • 5 days
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.
|
Other adverse events
| Measure |
Oxycodone Hydrochloride
n=34 participants at risk
Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone injection
|
Morphine Sulphate
n=32 participants at risk
Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate injection
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.8%
4/34 • Number of events 4 • 5 days
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.
|
15.6%
5/32 • Number of events 5 • 5 days
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.
|
|
Gastrointestinal disorders
Constipation
|
20.6%
7/34 • Number of events 7 • 5 days
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.
|
9.4%
3/32 • Number of events 3 • 5 days
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
0.00%
0/32 • 5 days
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.
|
|
General disorders
Asthenia
|
0.00%
0/34 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Number of events 2 • 5 days
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.
|
9.4%
3/32 • Number of events 3 • 5 days
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.
|
|
Nervous system disorders
Somnolence
|
8.8%
3/34 • Number of events 3 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Nervous system disorders
Sedation
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
0.00%
0/32 • 5 days
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/34 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/34 • 5 days
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.
|
3.1%
1/32 • Number of events 1 • 5 days
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.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1 • 5 days
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.
|
0.00%
0/32 • 5 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place