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NCT03182686 · ClinicalTrials.gov registry record · Phase 3
AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee
A Phase 3 study, sponsored by Ampio Pharmaceuticals..
- Completed
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
NCT03182686: Completed Phase 3 study, sponsored by Ampio Pharmaceuticals..
NCT03182686 is a Phase 3 study that has completed, run by Ampio Pharmaceuticals.. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03182686, a Phase 3 study, has completed, sponsored by Ampio Pharmaceuticals..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
Study 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.
Primary Outcome
Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of WOMAC A Pain subscore, WOMAC C Function subscore, and PGA as composite endpoints. A patient in this study will be considered a responder for the purpose of efficacy analysis if the following criteria are met: (1) demonstration of ≥ 50% improvement AND a 1.0-unit change in pain OR 1.0-unit change in function OR If the patient does not meet this criterion, then
Interventions
- BIOLOGICAL 4 mL injection of Ampion
- DRUG 4 mL Injection of Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2017-12-07 |
| Phase | Phase 3 |
What the finished NCT03182686 record still lists
NCT03182686 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which 4 mL injection of Ampion is the first listed.
NCT03182686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03182686 about?
NCT03182686 is a clinical study titled "AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee". 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.
What is the current status of trial NCT03182686?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2017-06-19. Estimated completion is 2017-12-07.
What interventions are being tested in trial NCT03182686?
The interventions under investigation include: 4 mL injection of Ampion (BIOLOGICAL), 4 mL Injection of Placebo (DRUG).
Who is sponsoring clinical trial NCT03182686?
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 NCT03182686's enrollment target sits among peer trials
168 1459th of 2000 higher than 538 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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