At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 480 enrolled
Drug / intervention
4 mL injection of AMPION™ +1 morebiological
Likely dose
4 mL injection of AMPION™from 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.
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of the Knee
In Brief
A Phase 3 clinical trial evaluating 4 mL injection of AMPION™ and 4 mL injection of Placebo for Osteoarthritis of the Knee. Completed, enrolled 480 participants across 1 site.
Detailed Summary
This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedSep 22, 2015
Enrollment StartSep 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.8 years ago
Interventions
4 mL injection of AMPION™biological
4 mL Injection of Ampion
4 mL injection of Placebodrug
4 mL Injection of Placebo