Other Acute Postoperative PainPhase 3NCT01304134

Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

A Phase 3 study testing Oxycodone and Morphine in people with Other Acute Postoperative Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Other Acute Postoperative Pain
What is being tested?: Oxycodone and Morphine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: Mar 2010to Aug 2010
Phase: Phase 3
Are there results?: None posted in the registry

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 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
ASA I and II.
Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
Patients who are willing to participate in the study and have signed the written informed consent.
Negative pregnancy test result should be obtained for women of child-bearing age.

Who cannot join

Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
Body weight is less than or over ±15% of the standard body weight.
Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
Medical history of recovering from abnormal surgery anesthesia.
Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
Esophagus reflux disease.

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Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
Have known hypersensitivity to opioids.
Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.
Patients with shock.
Patients with COPD.
Patients can not understand the VAS or unable to use PCA.
Pregnant or parturient women.

Trial locations and contacts

1 site in 1 country.

China1 site

Investigational site
Beijing, Beijing Municipality, 100022

Other trials in China

About this study

Official title: A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.

Conditions: Other Acute Postoperative Pain
Being tested: Oxycodone, Morphine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxycodoneDrug
Also called Oxycodone Injection
dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours
MorphineDrug
Also called Morphine Injection
dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours

Study groups in NCT01304134
Study group	Role	What they receive
Oxycodone i.v.	Experimental	To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) Receives: Drug: Oxycodone
Morphine i.v.	Active comparator	To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) Receives: Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Measured: 3h post-operation
Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Measured: 24 hours post operation
Measuring VAS
Measuring resting and coughing VAS, assessing the intensity of pain
Measured: 48 hours post operation

Secondary outcomes (5)

Dosage
Total dosage of study drugs within 48h.
Measured: Within 48h
The dosage of other rescue analgesic drugs used within 48h post-operation.
The dosage of other rescue analgesic drugs used within 48h post-operation.
Measured: 48hrs
The invalid times and the total times of PCA application
The invalid times and the total times of PCA application
Measured: 48hrs
Satisfaction degree for analgesia
Satisfaction degree for analgesia after the treatment
Measured: 48hrs
AE occurrence and abnormal lab value
AE and normal lab value will be recorded during the study
Measured: 48hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Aug 2010

First posted25 Feb 2011 (estimated)
Study startMar 2010
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Other Acute 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: Single blind
Who is masked: Participant
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01304134
Sponsor's protocol ID: OXYI09-CN-302
Status last verified: Aug 2015
First submitted: 23 Feb 2011
Last updated: 11 Aug 2015
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment
ClinicalTrials.gov ID: NCT01304134
Acronym / sponsor ID: OXYI09-CN-302
Conditions: Other Acute 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: Mar 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 25 Feb 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Oxycodone i.v.	Experimental	Drug: OxycodoneTo determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)
Morphine i.v.	Active comparator	Drug: MorphineTo determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.
ASA I and II.
Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
Patients who are willing to participate in the study and have signed the written informed consent.

Key exclusion criteria (13 listed)

Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
Body weight is less than or over ±15% of the standard body weight.
Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
Medical history of recovering from abnormal surgery anesthesia.
Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).

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
OxycodoneAlso: Oxycodone Injectiondosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours	Drug	Oxycodone i.v.
MorphineAlso: Morphine Injectiondosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours	Drug	Morphine i.v.

Primary outcome

Measuring VAS
Time frame: 3h post-operation
Measuring resting and coughing VAS, assessing the intensity of pain
Measuring VAS
Time frame: 24 hours post operation
Measuring resting and coughing VAS, assessing the intensity of pain
Measuring VAS
Time frame: 48 hours post operation
Measuring resting and coughing VAS, assessing the intensity of pain

5 secondary outcomes

Dosage
Time frame: Within 48h
The dosage of other rescue analgesic drugs used within 48h post-operation.
Time frame: 48hrs
The invalid times and the total times of PCA application
Time frame: 48hrs
Satisfaction degree for analgesia
Time frame: 48hrs
AE occurrence and abnormal lab value
Time frame: 48hrs

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.

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.

Mundipharma China Ltd. study chair

Mundipharma China Ltd.

Mundipharma China Ltd. principal investigator

Investigational Site Beijing, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone and Morphine in people with Other Acute Postoperative Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 1 site in China.

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 6 inclusion and 13 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 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Measuring VAS (time frame: 3h post-operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01304134.

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 11 Aug 2015.