Ibuprofen Sodium Tension Headache Study
Summary
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
Timeline
- Start
- 2011-06
- Primary completion
- 2012-03
- Completion
- 2012-03
Outcome
Mixed primary results
registry analysis (superiority or other test); Ibuprofen Sodium vs Placebo; p <0.001; Least-Square (LS) mean difference 6.11 (95% CI 4.49 to 7.73) NCT01362491 ↗
registry MEAN Ibuprofen Sodium: 9.6 (Standard Deviation 4.8) units on scale NCT01362491 ↗
registry MEAN Placebo: 3.5 (Standard Deviation 4.2) units on scale NCT01362491 ↗
registry MEDIAN Ibuprofen Sodium: 40.6 (36.7 to 46.8) minutes NCT01362491 ↗
registry MEDIAN Ibuprofen (Motrin IB): 48.5 (45.5 to 53.5) minutes NCT01362491 ↗
registry analysis (superiority or other test); Ibuprofen Sodium vs Ibuprofen (Motrin IB); p = 0.253; Hazard Ratio (HR) 1.20 (95% CI 0.88 to 1.65) NCT01362491 ↗
Publications
- Packman E, Leyva R, Kellstein D. Onset of analgesia with ibuprofen sodium in tension-type headache: a randomized trial. J Pharm Health Care Sci. 2015 Apr 2;1:13. doi: 10.1186/s40780-015-0012-9. eCollection 2015.
- Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 400 mg | Oral |
Indications
No indication recorded.