At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 226 enrolled
Drug / intervention
Ibuprofen Sodium +2 moredrug
Likely dose
Ibuprofen Sodium 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ibuprofen Sodium Tension Headache Study
In Brief
A Phase 3 clinical trial evaluating Ibuprofen Sodium, Standard Ibuprofen, and 1 other intervention for Pain. Completed, enrolled 226 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionMar 2012
TodayJul 2026
First PostedMay 30, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.1 years ago
Interventions
Ibuprofen Sodiumdrug
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Standard Ibuprofendrug
Single-dose of standard ibuprofen tablets (400mg)
Placebodrug
Single-dose of placebo