Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy - Study Results

Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy (PROSTATECTOMY)

This study has been terminated.

( See termination reason in detailed description. )

Study NCT00346268 Information provided by Pfizer

First Received on June 28, 2006. Last Updated on September 21, 2011 History of Changes

Results First Received: September 21, 2011

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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was terminated prematurely due to slow recruitment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	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.

Participant Flow: Overall Study

	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

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Reporting Groups

	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.

Baseline Measures

	Parecoxib and Morphine	Placebo and Morphine	Total
Number of Participants [units: participants]	52	53	105
Age, Customized [units: participants]
< 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

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1. Primary:

Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery [ Time Frame: 24 hours post surgery ]

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2. Secondary:

Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery [ Time Frame: 48 hours post surgery ]

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3. Secondary:

Time to Last Administration of Morphine [ Time Frame: baseline (end of surgery) to 48 hours post surgery ]

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4. Secondary:

Amount of Blood Loss [ Time Frame: 48 hours post surgery ]

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5. Secondary:

Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units [ Time Frame: 48 hours post surgery ]

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6. Secondary:

Pain Intensity Score [ Time Frame: 12, 24, 36, and 48 hours post surgery ]

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7. Secondary:

Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score [ Time Frame: 24 and 48 hours post surgery ]

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8. Secondary:

Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score [ Time Frame: 24 and 48 hours post surgery ]

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9. Secondary:

Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score [ Time Frame: 24 and 48 hours post surgery ]

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10. Other Pre-specified:

Number of Participants With Rating of Global Evaluation of Study Medication [ Time Frame: 48 hours post surgery ]

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11. Other Pre-specified:

Number of Participants With Health Care Resource Utilization (HCRU) [ Time Frame: 24 and 48 hours post surgery ]

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12. Other Pre-specified:

Overall Analgesic Benefit Score (OABS) [ Time Frame: 24 and 48 hours post surgery ]

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13. Other Pre-specified:

Hemoglobin Concentration [ Time Frame: 24 hours post surgery ]

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14. Other Pre-specified:

Total Amount of Postoperative Drainage Fluid [ Time Frame: 24 hours post surgery ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

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
This study was terminated prematurely due to slow recruitment.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

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