Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Ampion multiple injections in knee osteoarthritis
NCT02184156Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Oct 2015
- Countries
- 1
- Sponsor
- Ampio Pharmaceuticals, Inc.
- Modality
- Small Molecules, Cyclic Peptides
- Conditions
- osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial in osteoarthritis (OA) comparing Ampion with Placebo (2 arms). Primary endpoints: Incidence and Severity of Adverse Events and Serious Adverse Events at 24 Weeks and Change in Knee Pain at 20 Weeks. Started Jun 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ampion
4 mL intra-articular injection of Ampion
Placebo
4 mL intra-articular injection of Placebo (Saline)
03
Who it enrols
Adults 40-85 with moderate to moderately severe OA knee pain (WOMAC Pain Subscale >= 1.5) and Kellgren Lawrence Grade II-IV. Excludes those with tense effusions, inflammatory/crystal arthropathies, acute fractures, or recent major knee injury.
04
Endpoints
Primary
Incidence and Severity of Adverse Events and Serious Adverse Events
Change in Knee Pain
Secondary
Change in Knee Function
Beyond the preview
Go deeper on NCT02184156.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT02184156.