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NCT03349645 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee
A Phase 3 study, sponsored by Ampio Pharmaceuticals..
- Terminated
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
NCT03349645: Clinical Trial Phase 3 study, sponsored by Ampio Pharmaceuticals..
NCT03349645 is a Phase 3 study that was terminated before completion, run by Ampio Pharmaceuticals.. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03349645, a Phase 3 study, was terminated before completion, sponsored by Ampio Pharmaceuticals..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
Study Summary
This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee
Primary Outcome
Incidence and severity of treatment emergent adverse events (TEAEs) evaluated up to 52 weeks, including the 12 weeks in the Main study AP-003-C (NCT03182686).
Interventions
- BIOLOGICAL 4 mL injection of AMPION™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2018-10-04 |
| Phase | Phase 3 |
Why NCT03349645 stopped before completion
NCT03349645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which 4 mL injection of AMPION™ is the first listed.
NCT03349645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03349645 about?
NCT03349645 is a clinical study titled "Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee". This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee
What is the current status of trial NCT03349645?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2017-12-08. Estimated completion is 2018-10-04.
What interventions are being tested in trial NCT03349645?
The interventions under investigation include: 4 mL injection of AMPION™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT03349645?
This trial is sponsored by Ampio Pharmaceuticals., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03349645's enrollment target sits among peer trials
94 1719th of 2000 higher than 279 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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