Back to resultsOxyNorm Capsules in Post-Operative Pain Study
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OxyNorm Capsules
Morphine tablet
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Patients of either sex aged 18 to 80 years inclusive.
- Patients who have given written informed consent to participate in the study.
- Able and willing to communicate with the investigator and his/her staff.
- Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
- Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.
Exclusion Criteria:
- Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
- Patients with ASA ≥ 3 .
- Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.
- Have known hypersensitivity to any of the study medications or related agents.
- Have taken analgesic medications within three hours (wash-out) prior to dosing.
- Have developed complications from the surgical procedure that would confound the study.
- Have a history of severe iatrogenic adverse experiences.
- Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
- Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
- Surgery in patients with epidural anesthesia
- Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
- Patients with medical history of recovering from abnormal surgery anesthesia.
- Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
- Patients with shock.
- Patients with COPD.
- According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OxyNorm Capsules
Morphine tablet
Arm Description
To determine the efficacy and safety of OxyNorm Capsules.
To determine the efficacy and safety of Morphine tablet.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Very Good
Good
Fair
Bad
Very Bad
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
Very Satisfied
Satisfied
Fair
Not Satisfied
Not Satisfied at all
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.
Full Information
NCT ID
NCT01675635
First Posted
April 25, 2012
Last Updated
February 23, 2018
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01675635
Brief Title
OxyNorm Capsules in Post-Operative Pain Study
Official Title
A Double-blind, Randomized, Parallel Group Study to Compare the Efficacy and Safety, of Oxycodone Immediate-release Capsules Versus Morphine Immediate-release Tablets in Hospitalized Patients With Moderate to Severe Pain Following Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OxyNorm Capsules
Arm Type
Experimental
Arm Description
To determine the efficacy and safety of OxyNorm Capsules.
Arm Title
Morphine tablet
Arm Type
Active Comparator
Arm Description
To determine the efficacy and safety of Morphine tablet.
Intervention Type
Drug
Intervention Name(s)
OxyNorm Capsules
Other Intervention Name(s)
OxyNorm
Intervention Description
dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
Intervention Type
Other
Intervention Name(s)
Morphine tablet
Other Intervention Name(s)
Morphine
Intervention Description
dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
Description
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
Time Frame
Baseline and 6h (±20min)
Secondary Outcome Measure Information:
Title
VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
Description
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
Time Frame
Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
Title
The Use of Rescue Analgesics During the 24-hour Observation Period
Description
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
Time Frame
24 hours after the first dose.
Title
VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
Description
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
Time Frame
Baseline and 6h (±20min)
Title
Sleeping Quality Assessment
Description
To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison
Sleeping quality scale
Very Good
Good
Fair
Bad
Very Bad
Time Frame
24 hours after administration of first dose
Title
Satisfaction With Pain Control
Description
To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison
Very Satisfied
Satisfied
Fair
Not Satisfied
Not Satisfied at all
Time Frame
24 hours after administration of first dose
Title
Comparison of the Total Amount of Study Drugs Used During the 24 Hours
Description
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.
Time Frame
24 hours after administration of first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either sex aged 18 to 80 years inclusive.
Patients who have given written informed consent to participate in the study.
Able and willing to communicate with the investigator and his/her staff.
Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.
Exclusion Criteria:
Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
Patients with ASA ≥ 3 .
Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.
Have known hypersensitivity to any of the study medications or related agents.
Have taken analgesic medications within three hours (wash-out) prior to dosing.
Have developed complications from the surgical procedure that would confound the study.
Have a history of severe iatrogenic adverse experiences.
Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
Surgery in patients with epidural anesthesia
Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
Patients with medical history of recovering from abnormal surgery anesthesia.
Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
Patients with shock.
Patients with COPD.
According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XinMin Wu, Prof.
Organizational Affiliation
Peking University 1st Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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OxyNorm Capsules in Post-Operative Pain Study
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