Postoperative PainPhase 3NCT01675635
OxyNorm Capsules in Post-Operative Pain Study
A Phase 3 study testing OxyNorm Capsules and Morphine tablet in people with Postoperative Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd.
Trial summary
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- OxyNorm Capsules and Morphine tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jul 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this 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.
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- OxyNorm Capsules, Morphine tablet
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxyNorm CapsulesDrug
Also called OxyNorm
dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
Morphine tabletOther
Also called Morphine
dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| OxyNorm Capsules | Experimental | To determine the efficacy and safety of OxyNorm Capsules. Receives: Drug: OxyNorm Capsules |
| Morphine tablet | Active comparator | To determine the efficacy and safety of Morphine tablet. Receives: Other: Morphine tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)
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
Measured: Baseline and 6h (±20min)
Secondary outcomes (6)
VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison
Measured: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
The Use of Rescue Analgesics During the 24-hour Observation Period
To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison
Measured: 24 hours after the first dose.
VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
To measure coughing 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 bed as you can image applicable for both resting and coughing stage
Measured: Baseline and 6h (±20min)
Sleeping Quality Assessment
To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison
Sleeping quality scale
- Very Good
- Good
- Fair
- Bad
- Very Bad
Measured: 24 hours after administration of first dose
Satisfaction With Pain Control
To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison
- Very Satisfied
- Satisfied
- Fair
- Not Satisfied
- Not Satisfied at all
Measured: 24 hours after administration of first dose
Comparison of the Total Amount of Study Drugs Used During the 24 Hours
To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison
The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.
Measured: 24 hours after administration of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XinMin Wu, Prof., Principal investigator, Peking University 1st Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675635
- Sponsor's protocol ID
- OXYC11-CN-304
- Status last verified
- Nov 2017
- First submitted
- 25 Apr 2012
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01675635
- Acronym / sponsor ID
- OXYC11-CN-304
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 26 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxyNorm Capsules | Experimental | Drug: OxyNorm CapsulesTo determine the efficacy and safety of OxyNorm Capsules. |
| Morphine tablet | Active comparator | Other: Morphine tabletTo determine the efficacy and safety of Morphine tablet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxyNorm CapsulesAlso: OxyNormdosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours | Drug | OxyNorm Capsules |
| Morphine tabletAlso: Morphinedosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours. | Other | Morphine tablet |
Primary outcome
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
6 secondary outcomes
VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose
Time frame: Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)
The Use of Rescue Analgesics During the 24-hour Observation Period
Time frame: 24 hours after the first dose.
VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)
Time frame: Baseline and 6h (±20min)
Sleeping Quality Assessment
Time frame: 24 hours after administration of first dose
Satisfaction With Pain Control
Time frame: 24 hours after administration of first dose
Comparison of the Total Amount of Study Drugs Used During the 24 Hours
Time frame: 24 hours after administration of first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XinMin Wu, Prof. principal investigator
Peking University 1st Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OxyNorm Capsules and Morphine tablet in people with Postoperative Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose) (time frame: Baseline and 6h (±20min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.