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NCT02242435 · ClinicalTrials.gov registry record · Phase 3

A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

A Phase 3 study, sponsored by Ampio Pharmaceuticals..

Completed
Registry status
Phase 3
Development phase
342
Enrollment target

NCT02242435: Completed Phase 3 study, sponsored by Ampio Pharmaceuticals..

NCT02242435 is a Phase 3 study that has completed, run by Ampio Pharmaceuticals.. The registered enrollment target is 342 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02242435, a Phase 3 study, has completed, sponsored by Ampio Pharmaceuticals..

COMPLETED
Registry status
Phase 3
Development phase
342 participants
Enrollment target

Study Summary

This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to 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

  • BIOLOGICAL 4 mL injection of Ampion
  • DRUG 4 mL Injection of Placebo

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 2014-09
Est. Completion 2015-05
Phase Phase 3
Ampio Pharmaceuticals.

12 total trials

What the finished NCT02242435 record still lists

NCT02242435 is an interventional study that assigns participants to a tested intervention. The registered 342 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 (56% lower).

The record links to 0 conditions, and to 2 interventions - of which 4 mL injection of Ampion is the first listed.

NCT02242435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02242435 about?

NCT02242435 is a clinical study titled "A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis". This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

What is the current status of trial NCT02242435?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 342 participants. The study started on 2014-09. Estimated completion is 2015-05.

What interventions are being tested in trial NCT02242435?

The interventions under investigation include: 4 mL injection of Ampion (BIOLOGICAL), 4 mL Injection of Placebo (DRUG).

Who is sponsoring clinical trial NCT02242435?

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 NCT02242435's enrollment target sits among peer trials

342 1053rd of 2000 higher than 948 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 NCT02242435, the US trial registry maintained by the National Library of Medicine. NCT02242435 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.