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

NCT00346268 | Terminated Phase 4 Results DMC

• 1 other identifier: A3481066
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery

  Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.

  24 hours post surgery

Secondary Outcomes (8)

• Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery

  48 hours post surgery

• Time to Last Administration of Morphine

  baseline (end of surgery) to 48 hours post surgery

• Amount of Blood Loss

  48 hours post surgery

• Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units

  48 hours post surgery

• Pain Intensity Score

  12, 24, 36, and 48 hours post surgery

Other Outcomes (5)

• Number of Participants With Rating of Global Evaluation of Study Medication

  48 hours post surgery

• Number of Participants With Health Care Resource Utilization (HCRU)

  24 and 48 hours post surgery

• Overall Analgesic Benefit Score (OABS)

  24 and 48 hours post surgery

Study Arms (2)

Morphine plus Parecoxib

ACTIVE COMPARATOR

Drug: Morphine, Parecoxib

Morphine and Placebo

ACTIVE COMPARATOR

Drug: Morphine, Placebo

Interventions

Morphine, Parecoxib DRUG

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.

Morphine plus Parecoxib

Morphine, Placebo DRUG

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

Morphine and Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Cologne, 50924, Germany

Location

Pfizer Investigational Site

Essen, 45136, Germany

Location

Pfizer Investigational Site

Heidelberg, 69121, Germany

Location

Pfizer Investigational Site

Reutlingen, 72764, Germany

Location

Related Publications (1)

• Dirkmann D, Groeben H, Farhan H, Stahl DL, Eikermann M. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial. BMC Anesthesiol. 2015 Mar 9;15:31. doi: 10.1186/s12871-015-0015-y. eCollection 2015.

  PMID: 25767411 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; parecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated prematurely due to slow recruitment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 28, 2011
• Results First Posted: October 28, 2011

Record last verified: 2011-09

Locations

DE (4)