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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304134
Other study ID # OXYI09-CN-302
Secondary ID
Status Completed
Phase Phase 3
First received February 23, 2011
Last updated August 10, 2015
Start date March 2010
Est. completion date August 2010

Study information

Verified date August 2015
Source Mundipharma (China) Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%.

2. ASA I and II.

3. 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.

4. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.

5. Patients who are willing to participate in the study and have signed the written informed consent.

6. Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion Criteria:

1. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.

2. Body weight is less than or over ±15% of the standard body weight.

3. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).

4. Medical history of recovering from abnormal surgery anesthesia.

5. Medical history of hypertension (Systolic blood pressure =180Hg, Diastolic blood pressure 110Hg).

6. Esophagus reflux disease.

7. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.

8. Have known hypersensitivity to opioids.

9. Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days.

10. Patients with shock.

11. Patients with COPD.

12. Patients can not understand the VAS or unable to use PCA.

13. Pregnant or parturient women.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Investigational site Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Mundipharma (China) Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring VAS Measuring resting and coughing VAS, assessing the intensity of pain 3h post-operation No
Primary Measuring VAS Measuring resting and coughing VAS, assessing the intensity of pain 24 hours post operation No
Primary Measuring VAS Measuring resting and coughing VAS, assessing the intensity of pain 48 hours post operation No
Secondary Dosage Total dosage of study drugs within 48h. Within 48h No
Secondary The dosage of other rescue analgesic drugs used within 48h post-operation. The dosage of other rescue analgesic drugs used within 48h post-operation. 48hrs Yes
Secondary The invalid times and the total times of PCA application The invalid times and the total times of PCA application 48hrs No
Secondary Satisfaction degree for analgesia Satisfaction degree for analgesia after the treatment 48hrs No
Secondary AE occurrence and abnormal lab value AE and normal lab value will be recorded during the study 48hrs Yes
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