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Efficacy and Safety of Ultracet vs Ultram vs Placebo in Pain Following Oral Surgery
NCT00236483Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2002
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- tramadol
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial of tramadol in postoperative pain (3 arms), sponsored by Johnson & Johnson. Primary endpoints: Total Pain Relief, Sum of Pain Intensity Differences and 1 more. Started Nov 2002; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Ultracet
Tramadol HCl 75 mg / Acetaminophen 650 mg
Ultram
Tramadol HCl 100 mg
Placebo
Matching placebo
03
Who it enrols
Adult patients undergoing removal of at least 2 impacted third molars with moderate pain within 5 hours post-surgery. Excludes patients with history of substance abuse or inadequate relief from tramadol.
04
Endpoints
Primary
Total Pain Relief
Sum of Pain Intensity Differences
Sum of Total Pain Relief and Pain Intensity Differences
Secondary
Hourly Pain Relief
Time to Onset of Any Noticeable Decrease in Pain
Time to Meaningful Pain Relief
Time to Remedication
Patient Overall Medication Assessment
Safety Evaluations
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