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Completed

NCT Number: NCT01675635

OxyNorm Capsules in Post-Operative Pain Study

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OxyNorm Capsules

Drug

dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours

Other names: OxyNorm

Morphine tablet

Other

dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.

Other names: Morphine

Primary outcomes

  1. Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)

    Time frame: Baseline and 6h (±20min)

    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 outcomes

  1. VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose

    Time frame: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)

    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

  2. The Use of Rescue Analgesics During the 24-hour Observation Period

    Time frame: 24 hours after the first dose.

    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

  3. VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)

    Time frame: Baseline and 6h (±20min)

    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

  4. Sleeping Quality Assessment

    Time frame: 24 hours after administration of first dose

    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

  5. Satisfaction With Pain Control

    Time frame: 24 hours after administration of first dose

    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

  6. Comparison of the Total Amount of Study Drugs Used During the 24 Hours

    Time frame: 24 hours after administration of first dose

    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.

Sponsors and collaborators

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2012
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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