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The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OxyNorm Capsules | Experimental | To determine the efficacy and safety of OxyNorm Capsules. |
|
| Morphine tablet | Active Comparator | To determine the efficacy and safety of Morphine tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OxyNorm Capsules | Drug | dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose) | To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bad as you can image at resting stage | Baseline and 6h (±20min) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose | To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison | Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XinMin Wu, Prof. | Peking University 1st Hospital | Principal Investigator |
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There is no run-in or wash out period involved in this study.
On the protocol 240 subjects was planned to be enrolled, but actually 234 subjects was screened and all randomized. Zero screen failure is reasonable for the indication with this study design.
This study is a randomized, double blind, double dummy, multicenter, parallel group, comparative study to compare the efficacy and safety of oxycodone capsule versus morphine tablet. The subject recruited from hospitalized patients poor with moderate to severe pain following surgery. The duration of the study from 2011 Jul to 2011 Dec.
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| ID | Title | Description |
|---|---|---|
| FG000 | OxyNorm Capsules | To determine the efficacy and safety of OxyNorm Capsules. OxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours |
| FG001 | Morphine Tablet | To determine the efficacy and safety of Morphine tablet. Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OxyNorm Capsules | To determine the efficacy and safety of OxyNorm Capsules. OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours |
| BG001 | Morphine Tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose) | To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bad as you can image at resting stage | 234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6h (±20min) |
|
The protocol requires safety follow up until 24 hours after the last study medication dosing. So the longest time one subject in the study is 48 hours after the 1st study medication doing, include taking full of the 4 times dosing(intotal 24 hours) following by safety follow up for 24 hours.
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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 | OxyNorm Capsules | To determine the efficacy and safety of OxyNorm Capsules. OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Dan Zhu, Clinical operation and quality lead of the study | Mundipharma (China) pharmaceutical Co, LTD. | 0086-10-65636800 | medical.mcpc@mundipharma.com.cn |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine tablet | Other | dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. |
|
|
| The Use of Rescue Analgesics During the 24-hour Observation Period |
To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison |
| 24 hours after the first dose. |
| VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose) | To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage | Baseline and 6h (±20min) |
| Sleeping Quality Assessment | To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison Sleeping quality scale
| 24 hours after administration of first dose |
| Satisfaction With Pain Control | To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison
| 24 hours after administration of first dose |
| Comparison of the Total Amount of Study Drugs Used During the 24 Hours | To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose. | 24 hours after administration of first dose |
To determine the efficacy and safety of Morphine tablet.
Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Electrocardiogram test | the judgement of result normal, abnormal non clinical significant or abnormal clinical significant was made by the doctor according to the clinical practice. the study protocol does not have additional or particular requirement. | Count of Participants | Participants |
|
| America Society of Anesthesiologist classification | ASA Physical Status Classification System P1 A normal healthy patient P2 A patient with mild systemic disease P3 A patient with severe systemic disease P4 A patient with severe systemic disease that is a constant threat to life P5 A moribund patient who is not expected to survive without the operation P6 A declared brain-dead patient whose organ are being removed for donor purposes. | Count of Participants | Participants |
|
| OG001 | Morphine Tablet | To determine the efficacy and safety of Morphine tablet. Morphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. |
|
|
| Secondary | VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose | To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison | Posted | Mean | Standard Deviation | units on a scale | Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min) |
|
|
|
| Secondary | The Use of Rescue Analgesics During the 24-hour Observation Period | To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison | in FAS population | Posted | Count of Participants | Participants | 24 hours after the first dose. |
|
|
|
| Secondary | VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose) | To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage | 234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6h (±20min) |
|
|
|
| Secondary | Sleeping Quality Assessment | To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison Sleeping quality scale
| 234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis. | Posted | Count of Participants | Participants | 24 hours after administration of first dose |
|
|
|
| Secondary | Satisfaction With Pain Control | To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison
| 234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis. | Posted | Count of Participants | Participants | 24 hours after administration of first dose |
|
|
|
| Secondary | Comparison of the Total Amount of Study Drugs Used During the 24 Hours | To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose. | 234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis. | Posted | Mean | Standard Deviation | mg | 24 hours after administration of first dose |
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 35 |
| 117 |
| EG001 | Morphine Tablet | To determine the efficacy and safety of Morphine tablet. Morphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. | 0 | 117 | 0 | 117 | 35 | 117 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| backache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| postoperative infection | Infections and infestations | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| serum creatinine increase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| alanine aminotransferase increase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| fever | Infections and infestations | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| high tension | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| muculoskeletalache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| expectoration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| epigastric pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| aspartate aminotransferase increase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| glycosylated hemoglobin derease | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| blood glucose increase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| leucocyte count increase | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | General disorders | Non-systematic Assessment |
|
| chest uncomfortable | General disorders | Non-systematic Assessment |
|
| blood urea increase | Renal and urinary disorders | Non-systematic Assessment |
|
| swelling | General disorders | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 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 |
| Resting VAS 0.5 hour after first dose |
|
| Resting VAS 2 hours after first dose |
|
| Resting VAS 24 hours after first dose |
|
| Coughing baseline of Visual Analogue Scale |
|
| Coughing visual analogue scale before first dose |
|
| Coughing VAS 0.5 hour after first dose |
|
| Coughing VAS 2hours after first dose |
|
| Coughing VAS 24hours after first dose |
|
| Third dose interval(13-18) |
|
| Fourth dose interval(19-24h) |
|
| Fair |
|
| Bad |
|
| Very Bad |
|
| Fair |
|
| Not Satisfied |
|
| Not Satisfied at all |
|