Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Parecoxib/Valdecoxib for post-CABG pain
NCT00636064Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2003
- Countries
- 27
- Sponsor
- Pfizer
- Modality
- Orthosteric Ligands
- Drugs
- parecoxibvaldecoxib
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised, double-blind trial in postoperative pain comparing Parecoxib/Valdecoxib, Placebo/Valdecoxib and Placebo/Placebo (3 arms). Primary endpoint: Confirmed Clinically Relevant Adverse Events at Day 30. Started Jan 2003; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Parecoxib/Valdecoxib
Parecoxib IV followed by Valdecoxib Oral
Placebo/Valdecoxib
Placebo IV followed by Valdecoxib Oral
Placebo/Placebo
Placebo IV followed by Placebo Oral
03
Who it enrols
Patients undergoing elective primary isolated CABG via median sternotomy with CPB, expected to require pain medication for at least 3 days.
04
Endpoints
Primary
Confirmed Clinically Relevant Adverse Events
Secondary
Rate of supplemental analgesia consumed
Vital signs
Summed Pain Intensity over 8 hours
Opioid-related Symptoms Distress Scale
Time to last Patient Controlled Analgesia dose
Recovery measures
Incidence of specific confirmed CRAEs
Adverse events
Beyond the preview
Go deeper on NCT00636064.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00636064.