Completed

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.

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What is being tested

OxyNorm Capsules

+ Morphine tablet

DrugOther
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pathologic Processes

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorMundipharma (China) Pharmaceutical Co. Ltd
Last updated: February 26, 2018
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorMundipharma (China) Pharmaceutical Co. Ltd
Last updated: February 26, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Neurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain, Postoperative

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
To determine the efficacy and safety of OxyNorm Capsules.

Group II

Active Comparator
To determine the efficacy and safety of Morphine tablet.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers