OxyNorm Capsules in Post-Operative Pain Study

Mundipharma

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Treatments

Drug: OxyNorm Capsules

Other: Morphine tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01675635

OXYC11-CN-304

Details and patient eligibility

About

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

Full 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.

Enrollment

240 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.