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NCT03988023 · ClinicalTrials.gov registry record · Phase 3

Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

A Phase 3 study, sponsored by Ampio Pharmaceuticals..

Terminated
Registry status
Phase 3
Development phase
1,043
Enrollment target

NCT03988023: Clinical Trial Phase 3 study, sponsored by Ampio Pharmaceuticals..

NCT03988023 is a Phase 3 study that was terminated before completion, run by Ampio Pharmaceuticals.. The registered enrollment target is 1,043 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03988023, a Phase 3 study, was terminated before completion, sponsored by Ampio Pharmaceuticals..

TERMINATED
Registry status
Phase 3
Development phase
1,043 participants
Enrollment target

Study Summary

The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

Primary Outcome

Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.

Interventions

  • DRUG Saline
  • BIOLOGICAL Ampion

Trial Details

FieldValue
Enrollment Target 1,043 participants
Start Date 2019-06-24
Est. Completion 2021-07-13
Phase Phase 3
Ampio Pharmaceuticals.

12 total trials

Why NCT03988023 stopped before completion

NCT03988023 is an interventional study that assigns participants to a tested intervention. Its 1,043 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher).

The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.

NCT03988023 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03988023 about?

NCT03988023 is a clinical study titled "Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.". The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

What is the current status of trial NCT03988023?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,043 participants. The study started on 2019-06-24. Estimated completion is 2021-07-13.

What interventions are being tested in trial NCT03988023?

The interventions under investigation include: Saline (DRUG), Ampion (BIOLOGICAL).

Who is sponsoring clinical trial NCT03988023?

This trial is sponsored by Ampio Pharmaceuticals., which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03988023's enrollment target sits among peer trials

1,043 284th of 2000 higher than 1,717 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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Source: ClinicalTrials.gov NCT03988023, the US trial registry maintained by the National Library of Medicine. NCT03988023 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.