NCT01675635CompletedPhase 3
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.
Mundipharma (China) Pharmaceutical Co. Ltd0 sites240 target enrollmentStarted: July 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 240
- Primary Endpoint
- Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
OxyNorm Capsules
Experimental
To determine the efficacy and safety of OxyNorm Capsules.
Intervention: OxyNorm Capsules (Drug)
Morphine tablet
Active Comparator
To determine the efficacy and safety of Morphine tablet.
Intervention: Morphine tablet (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Satisfaction With Pain Control(24 hours after administration of first dose)
- VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose(Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min))
- Comparison of the Total Amount of Study Drugs Used During the 24 Hours(24 hours after administration of first dose)
- The Use of Rescue Analgesics During the 24-hour Observation Period(24 hours after the first dose.)
- Sleeping Quality Assessment(24 hours after administration of first dose)
- VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)(Baseline and 6h (±20min))
Investigators
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