Clinical trial NCT01675635: OxyNorm Capsules in Post-Operative Pain Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
timeFrame: Baseline and 6h (±20min)
Secondary outcomes:
measure: VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
timeFrame: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
measure: The Use of Rescue Analgesics During the 24-hour Observation Period
timeFrame: 24 hours after the first dose.
measure: VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
timeFrame: Baseline and 6h (±20min)
measure: Sleeping Quality Assessment
timeFrame: 24 hours after administration of first dose
measure: Satisfaction With Pain Control
timeFrame: 24 hours after administration of first dose
measure: Comparison of the Total Amount of Study Drugs Used During the 24 Hours
timeFrame: 24 hours after administration of first dose
Other outcomes:
Locations:
Study officials:
affiliation: Peking University 1st Hospital
name: XinMin Wu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: