At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Novel Ibuprofen +2 moredrug
Likely dose
Novel Ibuprofen 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.
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
In Brief
A Phase 3 clinical trial evaluating Novel Ibuprofen, Standard Ibuprofen, and 1 other intervention for Pain. Completed, enrolled 200 participants.
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 episodic tension-type headache.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartMar 2010
Primary CompletionOct 2010
TodayJul 2026
First PostedMar 1, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.3 years ago
Interventions
Novel Ibuprofendrug
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
Standard Ibuprofendrug
Single-dose of standard ibuprofen (400mg) plus placebo
Placebodrug
Single-dose of placebo