drugset / Trial / NCT01229449
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-09
- Completion
- 2009-09
Outcome
Met primary endpoint
registry analysis (superiority test); Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) vs Placebo; p <0.0001; ANOVA NCT01229449 ↗
registry analysis (superiority test); Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) vs Panadeine® Extra; p <0.0001; ANOVA NCT01229449 ↗
registry analysis (superiority test); Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) vs Nurofen Plus®; p = 0.0001; ANOVA NCT01229449 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 500 mg | Oral |
| Subject | Acetaminophen | Small molecule | 1000 mg | Oral |
| Comparator | Codeine | Small molecule | 25.6 mg | Oral |
| Comparator | Codeine | Small molecule | 30 mg | Oral |
| Subject | Ibuprofen | Small molecule | 200 mg | Oral |
| Subject | Ibuprofen | Small molecule | 400 mg | Oral |
Indications
No indication recorded.