drugset / Trial / NCT03003000
Ibuprofen/Caffeine Lower Back or Neck Pain Study
RandomizedParallel-groupDouble-blindTreatment
Summary
To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet and a placebo tablet.
Timeline
- Start
- 2016-12-20
- Primary completion
- 2017-09-24
- Completion
- 2017-09-28
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Ibuprofen and Caffeine; p = 0.3446; Mean Difference (Final Values) 0.156 (95% CI -0.168 to 0.480) NCT03003000 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | — |
| Subject | Ibuprofen | Small molecule | 400 mg | — |
Indications
No indication recorded.