CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 168 enrolled
Drug / intervention
4 mL injection of Ampion +1 morebiological
Likely dose
4 mL intra-articular injection of AmpionAI-extracted
Key inclusion· 6
  • ✓Clinical diagnosis of osteoarthritis supported by Kellgren-Lawrence Grade IV on x-ray within past 6 months
  • ✓Moderate to moderately-severe pain in study knee (WOMAC A pain subscale ≥1.5 on 5-point Likert scale)
  • ✓Moderate to moderately-severe function impairment in study knee (WOMAC C function subscale ≥1.5 on 5-point Likert scale)
  • ✓Ambulatory status maintained
Key exclusion· 11
  • ✕Any intra-articular injected medications in the study knee within 12 weeks prior to baseline or during study
  • ✕Use of opioid-containing analgesics
  • ✕Inflammatory or crystal arthropathies, acute fractures, aseptic necrosis, or joint replacement in the affected knee
  • ✕Major injury to study knee within 12 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03182686
NCT03182686Phase 3Completed
CompareCT.gov

A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Ampio Pharmaceuticals. Inc.·interventional·Posted Jun 9, 2017·Updated Aug 9, 2022

In Brief

A Phase 3 clinical trial evaluating 4 mL injection of Ampion and 4 mL Injection of Placebo for Osteoarthritis, Knee and 3 related conditions. Completed, enrolled 168 participants across 13 sites.

Detailed Summary

This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee, Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartJun 19, 2017
Primary CompletionDec 7, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.1 years ago

Interventions

4 mL injection of Ampionbiological

4 mL injection of Ampion

4 mL Injection of Placebodrug

4 mL Injection of Placebo