Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00346268

Purpose

The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Morphine, placebo Drug: Morphine, parecoxib	Phase IV

Drug Information available for: Parecoxib Parecoxib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy

Further study details as provided by Pfizer:

Primary Outcome Measures:

The main outcome is the evaluation of the total cumulative amount of morphine administered (PCA and bolus) in the 24 hours after the end of surgery (i.e. application of the last surgical stitch after radical prostatectomy). [ Time Frame: 24 hours after end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time of last administration of morphine (PCA and/or bolus dose). [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
The total cumulative amount of morphine administered (Patient Controlled Analgesia [PCA] and bolus) in the 48h after the end of surgery. [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory-Short Form (mBPI-sf) after 24 and 48 hours. [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
Health Care Resource Utilization (HCRU) 24 and 48 hours after surgery. [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
Assessment of adverse events 12, 24, 36, 48 hours after skin closure and at the Follow-up visit. [ Time Frame: 48 hours after skin closure ] [ Designated as safety issue: No ]
Time specific pain intensity (categorical scales) at rest and at movement 12, 24, 36, and 48 hours after end of surgery (defined as application of the last surgical stitch) [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
Patient's global evaluation of study medication 48 hours after skin closure. [ Time Frame: 48 hours after skin closure ] [ Designated as safety issue: No ]
Opiate Related Symptom Distress Scale Questionnaire (OR-SDS) after 24 and 48 hours. [ Time Frame: 48 hours after end of surgery ] [ Designated as safety issue: No ]
Patient global assessment of analgesic experience (Overall analgesic benefit score, OABS) 24 and 48 hours after skin closure. [ Time Frame: 48 hours after skin closure ] [ Designated as safety issue: No ]
Blood loss, defined as: ([Hb g/dL]pra + RBCUduring48 ) - [Hb g/dL]@48, where ([Hb g/dL]pra is the blood hemoglobin concentration preoperatively, [Hb g/dL]@48 is the blood hemoglobin concentration 48h after skin closure, and RBCUduring48 is the number [ Time Frame: 48 hours after skin closure ] [ Designated as safety issue: No ]
of red blood cell units (RBCU) substituted during and after prostatectomy until 48 h after skin closure. [ Time Frame: 48 hours after skin closure ] [ Designated as safety issue: No ]
Hemoglobin concentration [ Time Frame: 24 hours + / - 3 hr ] [ Designated as safety issue: No ]
total amount of postoperative drainage fluid will be assessed 24 h after skin closure. [ Time Frame: 24 hrs after skin closure ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Morphine plus placebo: Active Comparator	Drug: Morphine, placebo Bolus plus PCA (Morphine: Patient controlled administration via pump PRN)
Morphine plus active drug: Active Comparator	Drug: Morphine, parecoxib Parecoxib, 40 mg loading dose IV plus 20 mg IV within 24 hours post surgery morphine bolus plus PCA

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.

Exclusion Criteria:

The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346268

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Germany
Pfizer Investigational Site	Recruiting
Reutlingen, Germany, 72764
Pfizer Investigational Site	Recruiting
Essen, Germany, 45136
Pfizer Investigational Site	Active, not recruiting
Koeln-Lindenthal, Germany, 50925

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3481066
Study First Received:	June 28, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00346268
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Morphine
Signs and Symptoms
Parecoxib

Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009