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.
OxyNorm Capsules
+ Morphine tablet
Neurologic Manifestations+4
+ Pain
+ Pathologic Processes
Treatment Study
Summary
Study start date: July 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives