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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. oktober 2008 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1671

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
    • Queensland
      • Auchenflower, Queensland, Australien, 4066
        • Pfizer Investigational Site
    • South Australia
      • Ashford, South Australia, Australien, 5035
        • Pfizer Investigational Site
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Pfizer Investigational Site
  • Belgien
      • Brussel, Belgien, 1090
        • Pfizer Investigational Site
      • Bruxelles, Belgien, 1070
        • Pfizer Investigational Site
      • Edegem, Belgien, 2650
        • Pfizer Investigational Site
      • Genk, Belgien, 3600
        • Pfizer Investigational Site
      • Liege, Belgien, 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
  • Danmark
      • Kobenhavn, Danmark, 2100
        • Pfizer Investigational Site
      • Odense C, Danmark, 5000
        • Pfizer Investigational Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 119992
        • Pfizer Investigational Site
      • Moscow, Den Russiske Føderation, 123182
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Edinburgh, Det Forenede Kongerige, Eh3 9YW
        • Pfizer Investigational Site
      • Liverpool, Det Forenede Kongerige
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, SE1 7EH
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, E2 9JX
        • Pfizer Investigational Site
      • Middlesbrough, Det Forenede Kongerige, TS4 3BW
        • Pfizer Investigational Site
      • Oxford, Det Forenede Kongerige, OX3 9DU
        • Pfizer Investigational Site
  • Finland
      • Kuopio, Finland
        • Pfizer Investigational Site
      • Kuopio, Finland, 70211
        • Pfizer Investigational Site
      • Oulu, Finland
        • Pfizer Investigational Site
      • Turku, Finland, FIN-20520
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Fairhope, Alabama, Forenede Stater, 36532
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36608
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36604
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36607
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36602
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • Pfizer Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • Pfizer Investigational Site
      • Springdale, Arkansas, Forenede Stater, 72764
        • Pfizer Investigational Site
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Pfizer Investigational Site
      • Anaheim, California, Forenede Stater, 92805
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90033
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90095-1778
        • Pfizer Investigational Site
      • Orange, California, Forenede Stater, 92868
        • Pfizer Investigational Site
      • Sacramento, California, Forenede Stater, 95825
        • Pfizer Investigational Site
      • Sacramento, California, Forenede Stater, 95819
        • Pfizer Investigational Site
      • San Francisco, California, Forenede Stater, 94115
        • Pfizer Investigational Site
      • San Francisco, California, Forenede Stater, 94118-3110
        • Pfizer Investigational Site
      • San Francisco, California, Forenede Stater, 94143-0648
        • Pfizer Investigational Site
      • Santa Rosa, California, Forenede Stater, 95403
        • Pfizer Investigational Site
      • Santa Rosa, California, Forenede Stater, 95404
        • Pfizer Investigational Site
      • Stanford, California, Forenede Stater, 94305
        • Pfizer Investigational Site
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Pfizer Investigational Site
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Pfizer Investigational Site
      • New Haven, Connecticut, Forenede Stater, 06504
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, Forenede Stater, 33511
        • Pfizer Investigational Site
      • Clearwater, Florida, Forenede Stater, 33756
        • Pfizer Investigational Site
      • Hudson, Florida, Forenede Stater, 34667
        • Pfizer Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32216
        • Pfizer Investigational Site
      • Melbourne, Florida, Forenede Stater, 32901
        • Pfizer Investigational Site
      • Melbourne, Florida, Forenede Stater, 32901-3276
        • Pfizer Investigational Site
      • Pensacola, Florida, Forenede Stater, 32504
        • Pfizer Investigational Site
      • Pensacola, Florida, Forenede Stater, 32514
        • Pfizer Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • Pfizer Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Forenede Stater, 30901
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Pfizer Investigational Site
      • Salisbury, Maryland, Forenede Stater, 21801
        • Pfizer Investigational Site
      • Takoma Park, Maryland, Forenede Stater, 20912
        • Pfizer Investigational Site
      • Towson, Maryland, Forenede Stater, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Pfizer Investigational Site
      • Cambridge, Massachusetts, Forenede Stater, 02138
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Pfizer Investigational Site
      • Livonia, Michigan, Forenede Stater, 48150
        • Pfizer Investigational Site
      • Muskegon, Michigan, Forenede Stater, 49444
        • Pfizer Investigational Site
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10029
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14621
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45236
        • Pfizer Investigational Site
      • Dayton, Ohio, Forenede Stater, 45408
        • Pfizer Investigational Site
      • Dayton, Ohio, Forenede Stater, 45414
        • Pfizer Investigational Site
      • Sandusky, Ohio, Forenede Stater, 44870
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16601
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Pfizer Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29406
        • Pfizer Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29401
        • Pfizer Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29424
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Pfizer Investigational Site
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76107
        • Pfizer Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76107-2699
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
      • Irving, Texas, Forenede Stater, 75061
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Pfizer Investigational Site
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • Pfizer Investigational Site
      • Falls Church, Virginia, Forenede Stater, 22042
        • Pfizer Investigational Site
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Pfizer Investigational Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • Pfizer Investigational Site
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Pfizer Investigational Site
    • Wisconsin
      • Elkhorn, Wisconsin, Forenede Stater, 53121
        • Pfizer Investigational Site
      • Madison, Wisconsin, Forenede Stater, 53792
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Pfizer Investigational Site
  • Holland
      • Breda, Holland, 4836 AE
        • Pfizer Investigational Site
      • Eindhoven, Holland, 5623 EJ
        • Pfizer Investigational Site
      • Zwolle, Holland, 8011 JW
        • Pfizer Investigational Site
  • Irland
      • Dublin, Irland
        • Pfizer Investigational Site
  • Israel
      • Beer Sheva, Israel
        • Pfizer Investigational Site
      • Haifa, Israel
        • Pfizer Investigational Site
      • Haifa, Israel, 34362
        • Pfizer Investigational Site
      • Holon, Israel, 58100
        • Pfizer Investigational Site
      • Jerusalem, Israel, 91120
        • Pfizer Investigational Site
      • Jerusalem, Israel, 91031
        • Pfizer Investigational Site
      • Jerusalem, Israel, 91004
        • Pfizer Investigational Site
      • Petach-Tikva, Israel, 49261
        • Pfizer Investigational Site
      • Ramat-Gan, Israel
        • Pfizer Investigational Site
      • Rehovot, Israel
        • Pfizer Investigational Site
      • Tel Aviv, Israel
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52651
        • Pfizer Investigational Site
  • Italien
      • Firenze, Italien, 50134
        • Pfizer Investigational Site
      • Milano, Italien, 20138
        • Pfizer Investigational Site
      • Pavia, Italien, 27100
        • Pfizer Investigational Site
      • Pisa, Italien, 56125
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico City, DF, Mexico, 03100
        • Pfizer Investigational Site
      • Mexico City, DF, Mexico, 06720
        • Pfizer Investigational Site
      • Mexico City, DF, Mexico, 14050
        • Pfizer Investigational Site
    • Mexico DF
      • Mexico City, Mexico DF, Mexico, 07760
        • Pfizer Investigational Site
    • Mexico, DF
      • Mexico City, Mexico, DF, Mexico, 14000
        • Pfizer Investigational Site
  • Norge
      • Feiring, Norge, 2093
        • Pfizer Investigational Site
  • Polen
      • Bialystok, Polen, 15-276
        • Pfizer Investigational Site
      • Krakow, Polen, 31-202
        • Pfizer Investigational Site
      • Poznan, Polen, 61-848
        • Pfizer Investigational Site
      • Szczecin, Polen, 70-111
        • Pfizer Investigational Site
      • Warszawa, Polen, 02-097
        • Pfizer Investigational Site
  • Rumænien
      • Bucharest, Rumænien, 7000
        • Pfizer Investigational Site
      • Bucharest, Rumænien, 771181
        • Pfizer Investigational Site
      • Bucuresti, Rumænien, 7000
        • Pfizer Investigational Site
      • Bucuresti, Rumænien, 71406
        • Pfizer Investigational Site
      • Cluj-Napoca, Rumænien, 3400
        • Pfizer Investigational Site
      • Timisoara, Rumænien, 1900
        • Pfizer Investigational Site
  • Schweiz
      • Bern, Schweiz, 3010
        • Pfizer Investigational Site
      • Geneve 14, Schweiz, 1211
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 168752
        • Pfizer Investigational Site
  • Slovakiet
      • Bratislava, Slovakiet, 833 48
        • Pfizer Investigational Site
      • Kosice, Slovakiet, 040-11
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08025
        • Pfizer Investigational Site
      • Barcelona, Spanien, 08907
        • Pfizer Investigational Site
      • Madrid, Spanien, 28046
        • Pfizer Investigational Site
      • Valencia, Spanien, 46010
        • Pfizer Investigational Site
  • Sverige
      • Orebro, Sverige, SE-701 85
        • Pfizer Investigational Site
      • Stockholm, Sverige, 171 76
        • Pfizer Investigational Site
      • Uppsala, Sverige, SE 751 85
        • Pfizer Investigational Site
  • Sydafrika
      • Bloemfontein, Sydafrika, 9300
        • Pfizer Investigational Site
      • Pretoria, Sydafrika, 0002
        • Pfizer Investigational Site
      • Pretoria, Sydafrika, 0040
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, Sydafrika
        • Pfizer Investigational Site
    • Gauteng
      • Pretoria, Gauteng, Sydafrika
        • Pfizer Investigational Site
      • Pretoria, Gauteng, Sydafrika, 0002
        • Pfizer Investigational Site
      • Pretoria, Gauteng, Sydafrika, 0084
        • Pfizer Investigational Site
    • Gauteng Province
      • Johannesburg, Gauteng Province, Sydafrika
        • Pfizer Investigational Site
      • Pretoria, Gauteng Province, Sydafrika, 0140
        • Pfizer Investigational Site
    • KwaZulu Natal
      • Durban, KwaZulu Natal, Sydafrika
        • Pfizer Investigational Site
    • Pretoria
      • Les Marais, Pretoria, Sydafrika, 0084
        • Pfizer Investigational Site
    • Western Cape
      • Parow, Western Cape, Sydafrika, 7500
        • Pfizer Investigational Site
  • Tjekkiet
      • Ceske Budejovice, Tjekkiet, 370 87
        • Pfizer Investigational Site
      • Prague, Tjekkiet, 100 34
        • Pfizer Investigational Site
      • Prague, Tjekkiet, 128 00
        • Pfizer Investigational Site
      • Prague, Tjekkiet, 14220
        • Pfizer Investigational Site
      • Prague, Tjekkiet, 150 00
        • Pfizer Investigational Site
      • Prague 5, Tjekkiet, 15500
        • Pfizer Investigational Site
  • Tyskland
      • Aachen, Tyskland, 52074
        • Pfizer Investigational Site
      • Bonn, Tyskland, 53105
        • Pfizer Investigational Site
      • Giessen, Tyskland, 35385
        • Pfizer Investigational Site
      • Goettingen, Tyskland, 37075
        • Pfizer Investigational Site
      • Hamburg, Tyskland, 20251
        • Pfizer Investigational Site
      • Heidelberg, Tyskland, 69120
        • Pfizer Investigational Site
      • Kassel, Tyskland, 34125
        • Pfizer Investigational Site
      • Kiel, Tyskland, 24105
        • Pfizer Investigational Site
      • Muenchen, Tyskland, 81377
        • Pfizer Investigational Site
      • Muenster, Tyskland, 48149
        • Pfizer Investigational Site
  • Østrig
      • Graz, Østrig, 8036
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: B
Medicin: 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.
Eksperimentel: C
Andet: 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.
Placebo komparator: EN
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Combined incidence of the number of patients with at least 1 confirmed clinically relevant adverse event (CRAE)
Tidsramme: Day 30
Day 30

Sekundære resultatmål

Resultatmål
Tidsramme
Uønskede hændelser
Tidsramme: Dag 30
Dag 30
Vitale tegn
Tidsramme: Dag 30
Dag 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
Tidsramme: Day 30
Day 30
Rate of supplemental analgesia consumed
Tidsramme: Days 1-10
Days 1-10
Summed Pain Intensity (SPI) of sternotomy alone and overall body pain over 8 hours (SPI 8)
Tidsramme: Day 1
Day 1
Opioid-related Symptoms Distress Scale (OR-SDS)
Tidsramme: 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
Tidsramme: Day 30
Day 30
Serious adverse events
Tidsramme: Day 30
Day 30
Clinical laboratory assessments
Tidsramme: Day 30
Day 30
Peak Pain Intensity (PPI) of sternotomy alone and overall body pain
Tidsramme: Days 1-10
Days 1-10
Patient's and Physician's Global Evaluation of Study Medication
Tidsramme: 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)
Tidsramme: Days 1-10
Days 1-10
SPI of sternotomy alone and overall body pain over 12 hours (SPI 12) and 24 hours (SPI 24)
Tidsramme: Days 1-10
Days 1-10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2003

Studieafslutning (Faktiske)

1. januar 2004

Datoer for studieregistrering

Først indsendt

7. marts 2008

Først indsendt, der opfyldte QC-kriterier

7. marts 2008

Først opslået (Skøn)

14. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2008

Sidst verificeret

1. marts 2008

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PARA-0505-071
  • A3481015

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Parecoxib Sodium/Valdecoxib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner