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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00346268
First received: June 28, 2006
Last updated: September 21, 2011
Last verified: September 2011
  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, Parecoxib
Drug: Morphine, Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
    Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.

  • Time to Last Administration of Morphine [ Time Frame: baseline (end of surgery) to 48 hours post surgery ] [ Designated as safety issue: No ]
    Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).

  • Amount of Blood Loss [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
    Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.

  • Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
  • Pain Intensity Score [ Time Frame: 12, 24, 36, and 48 hours post surgery ] [ Designated as safety issue: No ]

    Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).

    Movement defined as sitting up from a lying into a sitting position in bed.


  • Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score [ Time Frame: 24 and 48 hours post surgery ] [ Designated as safety issue: No ]
    mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).

  • Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score [ Time Frame: 24 and 48 hours post surgery ] [ Designated as safety issue: No ]
    mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.

  • Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score [ Time Frame: 24 and 48 hours post surgery ] [ Designated as safety issue: No ]
    Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms' OR-SDS scores; ranged from 1 to 4.


Enrollment: 105
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine plus Parecoxib Drug: Morphine, Parecoxib
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.
Active Comparator: Morphine and Placebo Drug: Morphine, Placebo
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

Detailed Description:

The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Pfizer Investigational Site
Essen, Germany, 45136
Pfizer Investigational Site
Heidelberg, Germany, 69121
Pfizer Investigational Site
Koeln, Germany, 50924
Pfizer Investigational Site
Reutlingen, Germany, 72764
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Parecoxib
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014