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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
Pain, Postoperative |
| Interventions: |
Drug: Morphine, Parecoxib Drug: Morphine, Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| This study was terminated prematurely due to slow recruitment. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Parecoxib and Morphine | Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. |
| Placebo and Morphine | Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. |
| Parecoxib and Morphine | Placebo and Morphine | |
|---|---|---|
| STARTED | 52 | 53 |
| COMPLETED | 50 | 50 |
| NOT COMPLETED | 2 | 3 |
| Adverse Event | 1 | 0 |
| Protocol Violation | 1 | 0 |
| Participant refused | 0 | 3 |
Baseline Characteristics
| Description | |
|---|---|
| Parecoxib and Morphine | Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. |
| Placebo and Morphine | Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA. |
| Parecoxib and Morphine | Placebo and Morphine | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
52 | 53 | 105 |
|
Age, Customized
[units: participants] |
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| < 45 years | 0 | 0 | 0 |
| Between 45 and 59 years | 14 | 13 | 27 |
| Between 60 and 74 years | 36 | 38 | 74 |
| >= 75 years | 2 | 2 | 4 |
|
Gender
[units: participants] |
|||
| Female | 0 | 0 | 0 |
| Male | 52 | 53 | 105 |
Outcome Measures
| 1. Primary: | Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery [ Time Frame: 24 hours post surgery ] |
| 2. Secondary: | Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery [ Time Frame: 48 hours post surgery ] |
| 3. Secondary: | Time to Last Administration of Morphine [ Time Frame: baseline (end of surgery) to 48 hours post surgery ] |
| 4. Secondary: | Amount of Blood Loss [ Time Frame: 48 hours post surgery ] |
| 5. Secondary: | Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units [ Time Frame: 48 hours post surgery ] |
| 6. Secondary: | Pain Intensity Score [ Time Frame: 12, 24, 36, and 48 hours post surgery ] |
| 7. Secondary: | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score [ Time Frame: 24 and 48 hours post surgery ] |
| 8. Secondary: | Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score [ Time Frame: 24 and 48 hours post surgery ] |
| 9. Secondary: | Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score [ Time Frame: 24 and 48 hours post surgery ] |
| 10. Other Pre-specified: | Number of Participants With Rating of Global Evaluation of Study Medication [ Time Frame: 48 hours post surgery ] |
| 11. Other Pre-specified: | Number of Participants With Health Care Resource Utilization (HCRU) [ Time Frame: 24 and 48 hours post surgery ] |
| 12. Other Pre-specified: | Overall Analgesic Benefit Score (OABS) [ Time Frame: 24 and 48 hours post surgery ] |
| 13. Other Pre-specified: | Hemoglobin Concentration [ Time Frame: 24 hours post surgery ] |
| 14. Other Pre-specified: | Total Amount of Postoperative Drainage Fluid [ Time Frame: 24 hours post surgery ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| This study was terminated prematurely due to slow recruitment. |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00346268 History of Changes |
| Other Study ID Numbers: | A3481066 |
| Study First Received: | June 28, 2006 |
| Results First Received: | September 21, 2011 |
| Last Updated: | September 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |