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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.
5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone Hydrochloride | Experimental | Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride |
|
| Morphine Sulphate | Active Comparator | Brand name: BC Morphine sulfate Generic name: Morphine sulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone Hydrochloride | Drug | Oxycodone injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinhyong Kang, Dr. Ph.D | Seoul St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29670416 | Derived | Lee KH, Kang JH, Oh HS, Choi MK, Shim BY, Eum YJ, Park HJ, Kang JH. Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study. Pain Res Manag. 2017;2017:9741729. doi: 10.1155/2017/9741729. Epub 2017 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Morphine Sulphate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Morphine Sulphate | Drug | Morphine sulphate injection |
|
|
| 5 days |
| 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). | 5 days |
| 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). | 5 days |
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. |
| Safety Analysis Set |
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| FAS Set |
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| Per Protocol Set |
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| COMPLETED |
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| NOT COMPLETED |
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Demographic data was analysed FAS set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodone Hydrochloride | Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride Oxycodone Hydrochloride: Oxycodone IV injection |
| BG001 | Morphine Sulphate | Brand name: BC Morphine sulfate Generic name: Morphine sulfate Morphine Sulphate: Morphine sulphate IV injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Primary endpoint was analysed FAS set. | Posted | Mean | Standard Deviation | units on a scale | 5 days |
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| 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) | FAS set. | Posted | Mean | Standard Deviation | mg | 5 days |
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| 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). | 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. | Posted | Count of Participants | Participants | 5 days |
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| 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). | 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. | Posted | Count of Participants | Participants | 5 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxycodone Hydrochloride | Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride Oxycodone Hydrochloride: Oxycodone injection | 0 | 34 | 3 | 34 | 14 | 34 |
| EG001 | Morphine Sulphate | Brand name: BC Morphine sulfate Generic name: Morphine sulfate Morphine Sulphate: Morphine sulphate injection | 0 | 32 | 2 | 32 | 11 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Somnolence | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Sedation | Nervous system disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment | Adverse drug reaction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Suyoun Yang/CR head | Mundipharma Korea Ltd. | 82-2-527-9219 | suyoun.yang@mundipharma.co.kr |
| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
|
| 50-59 years |
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| 60-69 years |
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| Male |
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