drugset / Trial / NCT01118273
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
RandomizedParallel-groupTriple-blindTreatment
Summary
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
Timeline
- Start
- 2008-01
- Primary completion
- 2008-02
- Completion
- 2008-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg vs Naproxen Sodium 440 mg (BAYH6689); p = 0.54; ANCOVA NCT01118273 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diphenhydramine | Small molecule | 50 mg | Oral |
| Comparator | Diphenhydramine | Small molecule | 76 mg | Oral |
| Comparator | Ibuprofen | Small molecule | 400 mg | Oral |
| Subject | Naproxen | Small molecule | 220 mg | Oral |
| Subject | Naproxen | Small molecule | 440 mg | Oral |
Indications
No indication recorded.