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A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery

9 ottobre 2008 aggiornato da: Pfizer

A Double-Blind Multicenter Study of the Safety and Efficacy of Parecoxib Sodium/Valdecoxib and Placebo/Valdecoxib Compared to Placebo for Treatment of Post-Surgical Pain in Patients Who Have Coronary Bypass Graft Via Median Sternotomy

The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1671

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, 1118
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, 1416
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1405DCS
        • Pfizer Investigational Site
    • Pcia. de Buenos Aires
      • Morón, Pcia. de Buenos Aires, Argentina, 1708
        • Pfizer Investigational Site
  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Pfizer Investigational Site
    • South Australia
      • Ashford, South Australia, Australia, 5035
        • Pfizer Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Pfizer Investigational Site
  • Austria
      • Graz, Austria, 8036
        • Pfizer Investigational Site
  • Belgio
      • Brussel, Belgio, 1090
        • Pfizer Investigational Site
      • Bruxelles, Belgio, 1070
        • Pfizer Investigational Site
      • Edegem, Belgio, 2650
        • Pfizer Investigational Site
      • Genk, Belgio, 3600
        • Pfizer Investigational Site
      • Liege, Belgio, B-4000
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 5G2
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 5A5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Pfizer Investigational Site
  • Colombia
      • Bogota, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 000
        • Pfizer Investigational Site
    • Santander
      • Floridablanca, Santander, Colombia, 000
        • Pfizer Investigational Site
    • Valle
      • Cali, Valle, Colombia, Nap
        • Pfizer Investigational Site
  • Danimarca
      • Kobenhavn, Danimarca, 2100
        • Pfizer Investigational Site
      • Odense C, Danimarca, 5000
        • Pfizer Investigational Site
  • Federazione Russa
      • Moscow, Federazione Russa, 119992
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 123182
        • Pfizer Investigational Site
  • Finlandia
      • Kuopio, Finlandia
        • Pfizer Investigational Site
      • Kuopio, Finlandia, 70211
        • Pfizer Investigational Site
      • Oulu, Finlandia
        • Pfizer Investigational Site
      • Turku, Finlandia, FIN-20520
        • Pfizer Investigational Site
  • Germania
      • Aachen, Germania, 52074
        • Pfizer Investigational Site
      • Bonn, Germania, 53105
        • Pfizer Investigational Site
      • Giessen, Germania, 35385
        • Pfizer Investigational Site
      • Goettingen, Germania, 37075
        • Pfizer Investigational Site
      • Hamburg, Germania, 20251
        • Pfizer Investigational Site
      • Heidelberg, Germania, 69120
        • Pfizer Investigational Site
      • Kassel, Germania, 34125
        • Pfizer Investigational Site
      • Kiel, Germania, 24105
        • Pfizer Investigational Site
      • Muenchen, Germania, 81377
        • Pfizer Investigational Site
      • Muenster, Germania, 48149
        • Pfizer Investigational Site
  • Irlanda
      • Dublin, Irlanda
        • Pfizer Investigational Site
  • Israele
      • Beer Sheva, Israele
        • Pfizer Investigational Site
      • Haifa, Israele
        • Pfizer Investigational Site
      • Haifa, Israele, 34362
        • Pfizer Investigational Site
      • Holon, Israele, 58100
        • Pfizer Investigational Site
      • Jerusalem, Israele, 91120
        • Pfizer Investigational Site
      • Jerusalem, Israele, 91031
        • Pfizer Investigational Site
      • Jerusalem, Israele, 91004
        • Pfizer Investigational Site
      • Petach-Tikva, Israele, 49261
        • Pfizer Investigational Site
      • Ramat-Gan, Israele
        • Pfizer Investigational Site
      • Rehovot, Israele
        • Pfizer Investigational Site
      • Tel Aviv, Israele
        • Pfizer Investigational Site
      • Tel Hashomer, Israele, 52651
        • Pfizer Investigational Site
  • Italia
      • Firenze, Italia, 50134
        • Pfizer Investigational Site
      • Milano, Italia, 20138
        • Pfizer Investigational Site
      • Pavia, Italia, 27100
        • Pfizer Investigational Site
      • Pisa, Italia, 56125
        • Pfizer Investigational Site
  • Messico
    • DF
      • Mexico City, DF, Messico, 03100
        • Pfizer Investigational Site
      • Mexico City, DF, Messico, 06720
        • Pfizer Investigational Site
      • Mexico City, DF, Messico, 14050
        • Pfizer Investigational Site
    • Mexico DF
      • Mexico City, Mexico DF, Messico, 07760
        • Pfizer Investigational Site
    • Mexico, DF
      • Mexico City, Mexico, DF, Messico, 14000
        • Pfizer Investigational Site
  • Norvegia
      • Feiring, Norvegia, 2093
        • Pfizer Investigational Site
  • Olanda
      • Breda, Olanda, 4836 AE
        • Pfizer Investigational Site
      • Eindhoven, Olanda, 5623 EJ
        • Pfizer Investigational Site
      • Zwolle, Olanda, 8011 JW
        • Pfizer Investigational Site
  • Polonia
      • Bialystok, Polonia, 15-276
        • Pfizer Investigational Site
      • Krakow, Polonia, 31-202
        • Pfizer Investigational Site
      • Poznan, Polonia, 61-848
        • Pfizer Investigational Site
      • Szczecin, Polonia, 70-111
        • Pfizer Investigational Site
      • Warszawa, Polonia, 02-097
        • Pfizer Investigational Site
  • Regno Unito
      • Edinburgh, Regno Unito, Eh3 9YW
        • Pfizer Investigational Site
      • Liverpool, Regno Unito
        • Pfizer Investigational Site
      • London, Regno Unito, SE1 7EH
        • Pfizer Investigational Site
      • London, Regno Unito, E2 9JX
        • Pfizer Investigational Site
      • Middlesbrough, Regno Unito, TS4 3BW
        • Pfizer Investigational Site
      • Oxford, Regno Unito, OX3 9DU
        • Pfizer Investigational Site
  • Repubblica Ceca
      • Ceske Budejovice, Repubblica Ceca, 370 87
        • Pfizer Investigational Site
      • Prague, Repubblica Ceca, 100 34
        • Pfizer Investigational Site
      • Prague, Repubblica Ceca, 128 00
        • Pfizer Investigational Site
      • Prague, Repubblica Ceca, 14220
        • Pfizer Investigational Site
      • Prague, Repubblica Ceca, 150 00
        • Pfizer Investigational Site
      • Prague 5, Repubblica Ceca, 15500
        • Pfizer Investigational Site
  • Romania
      • Bucharest, Romania, 7000
        • Pfizer Investigational Site
      • Bucharest, Romania, 771181
        • Pfizer Investigational Site
      • Bucuresti, Romania, 7000
        • Pfizer Investigational Site
      • Bucuresti, Romania, 71406
        • Pfizer Investigational Site
      • Cluj-Napoca, Romania, 3400
        • Pfizer Investigational Site
      • Timisoara, Romania, 1900
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 168752
        • Pfizer Investigational Site
  • Slovacchia
      • Bratislava, Slovacchia, 833 48
        • Pfizer Investigational Site
      • Kosice, Slovacchia, 040-11
        • Pfizer Investigational Site
  • Spagna
      • Barcelona, Spagna, 08025
        • Pfizer Investigational Site
      • Barcelona, Spagna, 08907
        • Pfizer Investigational Site
      • Madrid, Spagna, 28046
        • Pfizer Investigational Site
      • Valencia, Spagna, 46010
        • Pfizer Investigational Site
  • Stati Uniti
    • Alabama
      • Fairhope, Alabama, Stati Uniti, 36532
        • Pfizer Investigational Site
      • Mobile, Alabama, Stati Uniti, 36608
        • Pfizer Investigational Site
      • Mobile, Alabama, Stati Uniti, 36604
        • Pfizer Investigational Site
      • Mobile, Alabama, Stati Uniti, 36607
        • Pfizer Investigational Site
      • Mobile, Alabama, Stati Uniti, 36602
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85724
        • Pfizer Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, Stati Uniti, 72703
        • Pfizer Investigational Site
      • Springdale, Arkansas, Stati Uniti, 72764
        • Pfizer Investigational Site
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Pfizer Investigational Site
      • Anaheim, California, Stati Uniti, 92805
        • Pfizer Investigational Site
      • Los Angeles, California, Stati Uniti, 90033
        • Pfizer Investigational Site
      • Los Angeles, California, Stati Uniti, 90095-1778
        • Pfizer Investigational Site
      • Orange, California, Stati Uniti, 92868
        • Pfizer Investigational Site
      • Sacramento, California, Stati Uniti, 95825
        • Pfizer Investigational Site
      • Sacramento, California, Stati Uniti, 95819
        • Pfizer Investigational Site
      • San Francisco, California, Stati Uniti, 94115
        • Pfizer Investigational Site
      • San Francisco, California, Stati Uniti, 94118-3110
        • Pfizer Investigational Site
      • San Francisco, California, Stati Uniti, 94143-0648
        • Pfizer Investigational Site
      • Santa Rosa, California, Stati Uniti, 95403
        • Pfizer Investigational Site
      • Santa Rosa, California, Stati Uniti, 95404
        • Pfizer Investigational Site
      • Stanford, California, Stati Uniti, 94305
        • Pfizer Investigational Site
    • Colorado
      • Fort Collins, Colorado, Stati Uniti, 80524
        • Pfizer Investigational Site
      • Fort Collins, Colorado, Stati Uniti, 80528
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Pfizer Investigational Site
      • New Haven, Connecticut, Stati Uniti, 06504
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20010
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, Stati Uniti, 33511
        • Pfizer Investigational Site
      • Clearwater, Florida, Stati Uniti, 33756
        • Pfizer Investigational Site
      • Hudson, Florida, Stati Uniti, 34667
        • Pfizer Investigational Site
      • Jacksonville, Florida, Stati Uniti, 32216
        • Pfizer Investigational Site
      • Melbourne, Florida, Stati Uniti, 32901
        • Pfizer Investigational Site
      • Melbourne, Florida, Stati Uniti, 32901-3276
        • Pfizer Investigational Site
      • Pensacola, Florida, Stati Uniti, 32504
        • Pfizer Investigational Site
      • Pensacola, Florida, Stati Uniti, 32514
        • Pfizer Investigational Site
      • Sarasota, Florida, Stati Uniti, 34239
        • Pfizer Investigational Site
      • St. Petersburg, Florida, Stati Uniti, 33709
        • Pfizer Investigational Site
      • Tampa, Florida, Stati Uniti, 33613
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Stati Uniti, 30901
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, Stati Uniti, 46804
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21215
        • Pfizer Investigational Site
      • Salisbury, Maryland, Stati Uniti, 21801
        • Pfizer Investigational Site
      • Takoma Park, Maryland, Stati Uniti, 20912
        • Pfizer Investigational Site
      • Towson, Maryland, Stati Uniti, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Pfizer Investigational Site
      • Cambridge, Massachusetts, Stati Uniti, 02138
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Pfizer Investigational Site
      • Livonia, Michigan, Stati Uniti, 48150
        • Pfizer Investigational Site
      • Muskegon, Michigan, Stati Uniti, 49444
        • Pfizer Investigational Site
      • Royal Oak, Michigan, Stati Uniti, 48073
        • Pfizer Investigational Site
    • New York
      • New York, New York, Stati Uniti, 10029
        • Pfizer Investigational Site
      • Rochester, New York, Stati Uniti, 14621
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Stati Uniti, 45236
        • Pfizer Investigational Site
      • Dayton, Ohio, Stati Uniti, 45408
        • Pfizer Investigational Site
      • Dayton, Ohio, Stati Uniti, 45414
        • Pfizer Investigational Site
      • Sandusky, Ohio, Stati Uniti, 44870
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73112
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Stati Uniti, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Stati Uniti, 16601
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15224
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Pfizer Investigational Site
      • Charleston, South Carolina, Stati Uniti, 29406
        • Pfizer Investigational Site
      • Charleston, South Carolina, Stati Uniti, 29401
        • Pfizer Investigational Site
      • Charleston, South Carolina, Stati Uniti, 29424
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38120
        • Pfizer Investigational Site
    • Texas
      • Amarillo, Texas, Stati Uniti, 79106
        • Pfizer Investigational Site
      • Fort Worth, Texas, Stati Uniti, 76107
        • Pfizer Investigational Site
      • Fort Worth, Texas, Stati Uniti, 76107-2699
        • Pfizer Investigational Site
      • Houston, Texas, Stati Uniti, 77030
        • Pfizer Investigational Site
      • Irving, Texas, Stati Uniti, 75061
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • Pfizer Investigational Site
    • Virginia
      • Annandale, Virginia, Stati Uniti, 22003
        • Pfizer Investigational Site
      • Falls Church, Virginia, Stati Uniti, 22042
        • Pfizer Investigational Site
      • Fredericksburg, Virginia, Stati Uniti, 22401
        • Pfizer Investigational Site
      • Norfolk, Virginia, Stati Uniti, 23507
        • Pfizer Investigational Site
    • Washington
      • Tacoma, Washington, Stati Uniti, 98405
        • Pfizer Investigational Site
    • Wisconsin
      • Elkhorn, Wisconsin, Stati Uniti, 53121
        • Pfizer Investigational Site
      • Madison, Wisconsin, Stati Uniti, 53792
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Stati Uniti, 53215
        • Pfizer Investigational Site
  • Sud Africa
      • Bloemfontein, Sud Africa, 9300
        • Pfizer Investigational Site
      • Pretoria, Sud Africa, 0002
        • Pfizer Investigational Site
      • Pretoria, Sud Africa, 0040
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, Sud Africa
        • Pfizer Investigational Site
    • Gauteng
      • Pretoria, Gauteng, Sud Africa
        • Pfizer Investigational Site
      • Pretoria, Gauteng, Sud Africa, 0002
        • Pfizer Investigational Site
      • Pretoria, Gauteng, Sud Africa, 0084
        • Pfizer Investigational Site
    • Gauteng Province
      • Johannesburg, Gauteng Province, Sud Africa
        • Pfizer Investigational Site
      • Pretoria, Gauteng Province, Sud Africa, 0140
        • Pfizer Investigational Site
    • KwaZulu Natal
      • Durban, KwaZulu Natal, Sud Africa
        • Pfizer Investigational Site
    • Pretoria
      • Les Marais, Pretoria, Sud Africa, 0084
        • Pfizer Investigational Site
    • Western Cape
      • Parow, Western Cape, Sud Africa, 7500
        • Pfizer Investigational Site
  • Svezia
      • Orebro, Svezia, SE-701 85
        • Pfizer Investigational Site
      • Stockholm, Svezia, 171 76
        • Pfizer Investigational Site
      • Uppsala, Svezia, SE 751 85
        • Pfizer Investigational Site
  • Svizzera
      • Bern, Svizzera, 3010
        • Pfizer Investigational Site
      • Geneve 14, Svizzera, 1211
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

  • Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period
  • New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surgery
  • Body mass index of less than or equal to 40 kg/m2 and weight of >55 kg
  • Patients scheduled to undergo an isolated (bypass grafting only without valve replacement, significant aortic reconstruction, or ventriculoplasty) primary CABG surgery via median sternotomy, using cardiopulmonary bypass

Exclusion criteria:

  • Patient has undergone or is going to have emergency coronary artery bypass graft surgery or surgery without cardiopulmonary bypass procedure
  • Symptomatic peripheral vascular disease
  • Heart attack within 48 hours of surgery

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: B
Droga: Placebo/Valdecoxib
Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
Sperimentale: C
Altro: Placebo/Placebo
Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
Comparatore placebo: UN
Droga: Parecoxib Sodium/Valdecoxib
Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
Lasso di tempo: Day 30
Day 30

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Eventi avversi
Lasso di tempo: Giorno 30
Giorno 30
Segni vitali
Lasso di tempo: Giorno 30
Giorno 30
Combined incidence of the number of patients with at least 1 reported CRAE and the combined incidence of the number of patients with specific reported CRAEs summarized according to the categories listed above
Lasso di tempo: Day 30
Day 30
Rate of supplemental analgesia consumed
Lasso di tempo: Days 1-10
Days 1-10
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
Lasso di tempo: Day 1
Day 1
Opioid-related Symptoms Distress Scale (OR-SDS)
Lasso di tempo: Days 1-10
Days 1-10
Time to last Patient Controlled Analgesia (PCA) dose
Recovery measures (length of stay, intensive care unit/hospital recovery and eligibility for discharge)
Combined incidence of the number of patients with specific confirmed CRAEs in categories of cardiovascular thromboembolic CRAEs, renal CRAEs, upper gastrointestinal ulcer CRAEs, and wound healing complication CRAEs
Lasso di tempo: Day 30
Day 30
Serious adverse events
Lasso di tempo: Day 30
Day 30
Clinical laboratory assessments
Lasso di tempo: Day 30
Day 30
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
Lasso di tempo: Days 1-10
Days 1-10
Patient's and Physician's Global Evaluation of Study Medication
Lasso di tempo: At time of transition from intravenous to oral medication and final visit/early termination
At time of transition from intravenous to oral medication and final visit/early termination
Modified Brief Pain Inventory-short form (mBPI-sf)
Lasso di tempo: Days 1-10
Days 1-10
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
Lasso di tempo: Days 1-10
Days 1-10

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2003

Completamento dello studio (Effettivo)

1 gennaio 2004

Date di iscrizione allo studio

Primo inviato

7 marzo 2008

Primo inviato che soddisfa i criteri di controllo qualità

7 marzo 2008

Primo Inserito (Stima)

14 marzo 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 ottobre 2008

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2008

Ultimo verificato

1 marzo 2008

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PARA-0505-071
  • A3481015

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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