OxyNorm Capsules in Post-Operative Pain Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: OxyNorm Capsules
* Other: Morphine tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OxyNorm Capsules<br>To determine the efficacy and safety of OxyNorm Capsules. | Drug: OxyNorm Capsules<br>* dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours<br>* Other names: OxyNorm;|
| Active Comparator: Morphine tablet<br>To determine the efficacy and safety of Morphine tablet. | Other: Morphine tablet<br>* dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.<br>* Other names: Morphine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 Very Good Good Fair Bad Very Bad | 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 Very Satisfied Satisfied Fair Not Satisfied Not Satisfied at all | 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 |