OxyNorm Capsules in Post-Operative Pain Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01675635
First received: April 25, 2012
Last updated: October 8, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Postoperative Pain
Drug: OxyNorm Capsules
Other: Morphine tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Resting VAS at 6h after administration of first dose [ Time Frame: at 6h after administration of first dose ] [ Designated as safety issue: No ]
    To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to comduct inter-group comparison


Secondary Outcome Measures:
  • Coughing VAS at 6h after administration of first dose [ Time Frame: at 6h after administration of first dose ] [ Designated as safety issue: No ]
    To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to comduct inter-group comparison

  • The amount of rescue analgesics used during the 24-hour observation period [ Time Frame: during 24 hours period after the first dose. ] [ Designated as safety issue: No ]
    To calculate the amount of rescue analgesics used during the 24-hour observation period and to comduct inter-group comparison

  • Resting and coughing VAS at 0.5h, 2h and 24h after administration of first dose [ Time Frame: every 6 hours with the 24 hours period after first dose ] [ Designated as safety issue: No ]
    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 comduct inter-group comparison

  • Sleeping quality assessment [ Time Frame: 24 hours after administration of first dose ] [ Designated as safety issue: No ]
    To assess Sleeping quality assessment during 24 hours after administration of first dose and to comduct inter-group comparison

  • Satisfaction with pain control [ Time Frame: 24 hours after administration of first dose ] [ Designated as safety issue: No ]
    To assess the Satisfaction with pain control during 24 hours after administration of first dose and to comduct inter-group comparison

  • comparison of the total amount of study drugs used during the 24 hours [ Time Frame: 24 hours after administration of first dose ] [ Designated as safety issue: No ]
    To calculate the total amount of study drugs used during the 24 hours and to comduct inter-group comparison

  • the number and rate of AE and abnormal lab results [ Time Frame: 24-48 hours after administration of first dose ] [ Designated as safety issue: Yes ]
    To calculate the number and rate of each AE and abnormal lab results occuring in the study, and to conduct inter-group comparation.


Enrollment: 240
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 non-peros (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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01675635

Sponsors and Collaborators
Mundipharma Pte Ltd.
Investigators
Principal Investigator: XinMin Wu, Prof. Peking University 1st Hospital
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01675635     History of Changes
Other Study ID Numbers: OXYC11-CN-304
Study First Received: April 25, 2012
Last Updated: October 8, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 19, 2014