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

NCT ID: NCT00346268

Last Updated: 2011-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Morphine plus Parecoxib

Group Type ACTIVE_COMPARATOR

Morphine, Parecoxib

Intervention Type 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 and Placebo

Group Type ACTIVE_COMPARATOR

Morphine, Placebo

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cologne, , Germany

Site Status

Pfizer Investigational Site

Essen, , Germany

Site Status

Pfizer Investigational Site

Heidelberg, , Germany

Site Status

Pfizer Investigational Site

Reutlingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25767411 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3481066&StudyName=Morphine-Sparing%20Efficacy%20Of%20Parecoxib%20In%20Pain%20Treatment%20After%20Radical%20Prostatectomy

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Other Identifiers

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A3481066

Identifier Type: -

Identifier Source: org_study_id