OxyNorm Capsules in Post-Operative Pain Study

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.

The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: OxyNorm Capsules; Other: Morphine tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients of either sex aged 18 to 80 years inclusive.
2. Patients who have given written informed consent to participate in the study.
3. Able and willing to communicate with the investigator and his/her staff.
4. Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
5. Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.

Exclusion Criteria:

1. Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
2. Patients with ASA ≥ 3 .
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.
4. Have known hypersensitivity to any of the study medications or related agents.
5. Have taken analgesic medications within three hours (wash-out) prior to dosing.
6. Have developed complications from the surgical procedure that would confound the study.
7. Have a history of severe iatrogenic adverse experiences.
8. Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
9. Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
10. Surgery in patients with epidural anesthesia
11. Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
12. Patients with medical history of recovering from abnormal surgery anesthesia.
13. Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
14. Patients with shock.
15. Patients with COPD.
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OxyNorm Capsules; To determine the efficacy and safety of OxyNorm Capsules.	Drug: OxyNorm Capsules; dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours; Other Names: OxyNorm
ACTIVE_COMPARATOR: Morphine tablet; To determine the efficacy and safety of Morphine tablet.	Other: Morphine tablet; dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.; Other Names: Morphine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
• Investigators: Principal Investigator: XinMin Wu, Prof., Peking University 1st Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (ESTIMATE): August 30, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: OXYC11-CN-304