At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 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 Prospective Phase 1/2 Study to Evaluate the Safety and Exploratory 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 2 clinical trial evaluating 4 mL injection of Ampion and 4 mL injection of Placebo for Osteoarthritis of the Knee. Completed, enrolled 47 participants across 1 site.
Detailed Summary
Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2 weeks apart to adults with osteoarthritis of the knee. In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related AEs, enrollment will be initiated in Phase 2 of the study. Phase 2 will evaluate the efficacy of 3 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 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJun 2014
First PostedJul 2014
Primary CompletionOct 2015
TodayJul 2026
First PostedJul 9, 2014
Enrollment StartJun 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.0 years ago
Interventions
4 mL injection of Ampionbiological
4 mL injection of Ampion
4 mL injection of Placebodrug