OxyNorm Capsules in Post-Operative Pain Study

Last updated: February 23, 2018
Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Post-surgical Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT01675635
OXYC11-CN-304
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 atwhich time oral medication is indicated.

  5. Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requestinganalgesics for pain relief.

Exclusion

Exclusion Criteria:

  1. Patients have developed tolerance to or dependence on narcotic analgesics and/oralcohol.

  2. Patients with ASA ≥ 3 .

  3. Have any concomitant medical condition that would be adversely affected by analgesicsor 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 thestudy.

  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 timesupper 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 inclusioncriteria and exclusion criteria for any other reason than not suitable in this study.

Study Design

Total Participants: 240
Study Start date:
July 01, 2011
Estimated Completion Date:
July 31, 2012

Study 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.