Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages

NCT00763997

Last updated date
Study Location
BG University Hospital Bergmannsheil GmbH
Bochum, , 44789, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Platelet Aggregation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Planned traumatologic, orthopedic, visceral or plastic surgical procedures

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior intake of drugs with effect on the platelet aggregation


- Patients with diseases of the gastrointestinal systems


- Patients with cardiac or circulatory diseases


- Patients receiving corticoids


- Patients with cold or asthma


- ASA-classification > 3

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages
Official Title  ICMJE Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation
Brief Summary Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Platelet Aggregation
Intervention  ICMJE
  • Drug: dipyrone
    Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward
  • Drug: Ibuprofen
    Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day
  • Drug: Acetaminophen
    Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day
  • Drug: Acetaminophen
    Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day
  • Drug: Parecoxib/Valdecoxib
    40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day
  • Other: Blood samples
    Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
Study Arms  ICMJE
  • Experimental: 1
    Dipyrone
    Interventions:
    • Drug: dipyrone
    • Other: Blood samples
  • Active Comparator: 2
    Ibuprofen
    Interventions:
    • Drug: Ibuprofen
    • Other: Blood samples
  • Active Comparator: 3
    Acetaminophen
    Interventions:
    • Drug: Acetaminophen
    • Drug: Acetaminophen
    • Other: Blood samples
  • Placebo Comparator: 4
    Parecoxib/Valdecoxib
    Interventions:
    • Drug: Parecoxib/Valdecoxib
    • Other: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Planned traumatologic, orthopedic, visceral or plastic surgical procedures

Exclusion Criteria:

  • Prior intake of drugs with effect on the platelet aggregation
  • Patients with diseases of the gastrointestinal systems
  • Patients with cardiac or circulatory diseases
  • Patients receiving corticoids
  • Patients with cold or asthma
  • ASA-classification > 3
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763997
Other Study ID Numbers  ICMJE NRA3480005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthias Schmauß, MD, scientific associate with the Ruhr Unievrsity Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Matthias Schmauss, MDresearch associate of the Ruhr University Bochum
Study Chair:Christoph Maier, ProfessorLeader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum
PRS Account Ruhr University of Bochum
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP