At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 342 enrolled
Drug / intervention
4 mL injection of Ampion +1 morebiological
Likely dose
4 mL injection of Ampionfrom 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 Evaluate the Safety and Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart 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 342 participants across 1 site.
Detailed Summary
This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, 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
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedSep 2014
Primary CompletionApr 2015
Study CompletionMay 2015
TodayJul 2026
First PostedSep 17, 2014
Enrollment StartSep 1, 2014
Primary CompletionApr 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.8 years ago
Interventions
4 mL injection of Ampionbiological
4 mL injection of Ampion
4 mL Injection of Placebodrug