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OxyNorm Capsules in Post-Operative Pain Study

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ClinicalTrials.gov Identifier: NCT01675635
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: OxyNorm Capsules Other: Morphine tablet Phase 3

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Morphine



Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. Very Good
    2. Good
    3. Fair
    4. Bad
    5. 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

    1. Very Satisfied
    2. Satisfied
    3. Fair
    4. Not Satisfied
    5. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675635


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

Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01675635     History of Changes
Other Study ID Numbers: OXYC11-CN-304
First Posted: August 30, 2012    Key Record Dates
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018
Last Verified: November 2017

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents