Cancer Pain
Conditions
Keywords
Intravenous injection in cancer pain
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.
Detailed description
5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.
Interventions
Oxycodone injection
Morphine sulphate injection
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration | 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) |
| Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 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). |
| Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 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). |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone Hydrochloride Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride
Oxycodone Hydrochloride: Oxycodone IV injection | 33 |
| Morphine Sulphate Brand name: BC Morphine sulfate Generic name: Morphine sulfate
Morphine Sulphate: Morphine sulphate IV injection | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Oxycodone Hydrochloride | Morphine Sulphate |
|---|---|---|---|
| Age, Customized <39 years | 2 participants | 0 participants | 2 participants |
| Age, Customized 40-49 years | 3 participants | 1 participants | 2 participants |
| Age, Customized 50-59 years | 11 participants | 5 participants | 6 participants |
| Age, Customized 60-69 years | 49 participants | 27 participants | 22 participants |
| Region of Enrollment Korea, Republic of | 65 participants | 33 participants | 32 participants |
| Sex: Female, Male Female | 22 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 43 Participants | 21 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 14 / 34 | 11 / 32 |
| serious Total, serious adverse events | 3 / 34 | 2 / 32 |
Outcome results
Primary
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.
Time frame: 5 days
Population: Primary endpoint was analysed FAS set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Hydrochloride | Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. | -3.52 units on a scale | Standard Deviation 2.17 |
| Morphine Sulphate | Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5. | -3.13 units on a scale | Standard Deviation 1.84 |
Secondary
Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 3: Minimal improved | 5 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 5. Minimally worse | 0 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 2: Much improved | 16 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 6. Much worse | 0 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 4. No change | 1 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 7. Very much worse | 0 Participants |
| Oxycodone Hydrochloride | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 1: Very much improved | 10 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 7. Very much worse | 0 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 1: Very much improved | 9 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 2: Much improved | 15 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 3: Minimal improved | 6 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 4. No change | 1 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 5. Minimally worse | 0 Participants |
| Morphine Sulphate | Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization | 6. Much worse | 0 Participants |
Secondary
Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization
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
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 3: Minimally improved | 12 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 5: Minimally worse | 0 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 2: Much Improved | 10 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 6: Much worse | 0 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 4: No change | 1 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 7: Very much worse | 0 Participants |
| Oxycodone Hydrochloride | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 1:Very much improved | 9 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 7: Very much worse | 0 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 1:Very much improved | 8 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 2: Much Improved | 10 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 3: Minimally improved | 12 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 4: No change | 1 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 5: Minimally worse | 0 Participants |
| Morphine Sulphate | Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization | 6: Much worse | 0 Participants |
Secondary
Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
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
Population: FAS set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone Hydrochloride | Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration | 226.80 mg | Standard Deviation 110.44 |
| Morphine Sulphate | Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration | 226.64 mg | Standard Deviation 135.13 |