Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

NCT01304134 | Completed Phase 3 DMC

• 1 other identifier: OXYI09-CN-302
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Other Acute Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• Measuring VAS

  Measuring resting and coughing VAS, assessing the intensity of pain

  3h post-operation

• Measuring VAS

  Measuring resting and coughing VAS, assessing the intensity of pain

  24 hours post operation

• Measuring VAS

  Measuring resting and coughing VAS, assessing the intensity of pain

  48 hours post operation

Secondary Outcomes (5)

• Dosage

  Within 48h

• The dosage of other rescue analgesic drugs used within 48h post-operation.

  48hrs

• The invalid times and the total times of PCA application

  48hrs

• Satisfaction degree for analgesia

  48hrs

• AE occurrence and abnormal lab value

  48hrs

Study Arms (2)

Oxycodone i.v.

EXPERIMENTAL

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)

Drug: Oxycodone

Morphine i.v.

ACTIVE COMPARATOR

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA)

Drug: Morphine

Interventions

Oxycodone DRUG

dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours

Also known as: Oxycodone Injection

Oxycodone i.v.

Morphine DRUG

dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours

Also known as: Morphine Injection

Morphine i.v.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

Investigational site

Beijing, Beijing Municipality, 100022, China

Location

MeSH Terms

Interventions

Oxycodone; Morphine

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mundipharma China Ltd.

  Mundipharma China Ltd.

  STUDY CHAIR

• Mundipharma China Ltd.

  Investigational Site Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 25, 2011
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CN (1)