At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 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 Post-Surgical Dental Pain
In Brief
A Phase 3 clinical trial evaluating Novel Ibuprofen, Acetaminophen, and 1 other intervention for Pain. Completed, enrolled 218 participants across 1 site.
Detailed Summary
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedOct 2010
Primary CompletionJan 2011
TodayJul 2026
First PostedOct 7, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.7 years ago
Interventions
Novel Ibuprofendrug
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
Acetaminophendrug
Single-dose of acetaminophen (1000mg)
Placebodrug
Single-dose of placebo