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NGI226 for Achilles Tendinopathy

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 169 (end of study)

Awards & highlights

Study Summary

This trial will measure safety, tolerability, and improvement of Achilles tendon after injection of NGI226 MP in patients with mid-portion Achilles tendinopathy.

Who is the study for?

This trial is for individuals with mid-portion Achilles tendinopathy lasting over 8 weeks but less than a year, who haven't improved after at least 6 weeks of standard treatments like physiotherapy or NSAIDs. It's not suitable for those with conditions affecting injection safety, history of blood clots or frequent infections, past ankle surgeries or significant heart disease.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of NGI226 Microparticles given as a single peritendon injection to improve Achilles tendon mechanical properties compared to a placebo in patients with Achilles tendinopathy.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include local reactions at the injection site such as pain, swelling, and irritation. Systemic side effects could occur but would depend on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 169 (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 169 (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 169 (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with AEs and SAEs

Secondary outcome measures

Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NGI226Experimental Treatment1 Intervention

single peritendon injection

Group II: PlaceboPlacebo Group1 Intervention

single peritendon injection

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,198 Total Patients Enrolled

Media Library

NGI226 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05592990 — Phase 2

Achilles Tendinopathy Research Study Groups: NGI226, Placebo

Achilles Tendinopathy Clinical Trial 2023: NGI226 Highlights & Side Effects. Trial Name: NCT05592990 — Phase 2

NGI226 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05592990 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have an upper age limit?

"The proposed parameters for inclusion in this medical trial require the patient to be between 30 and 70 years old. Additionally, 3 additional trials are available for people younger than 18 while 57 studies have been designed for those over 65."

Answered by AI

What is the eligibility criteria for participating in this clinical study?

"This investigation seeks 53 individuals, aged between 30 and 70 years old that are currently enduring achilles tendinopathy. In order to qualify for the trial, patients must adhere to the following criteria:1) Provide written confirmation of consent prior to any screening-related procedures; 2) Display clinical signs (e.g., discomfort on tendon loading activities/palpation around 2-6 cm proximal from calcaneal insertion), as well as ultrasound or MRI evidence of mid portion Achilles tendinopathy with symptoms lasting between 8 weeks and 12 months at screening.; 3) Have attempted conservative treatment methods such as physical"

Answered by AI

Are there opportunities still available to join this medical investigation?

"The data found on clinicaltrials.gov indicates that at present this trial is not accepting any candidates, although the original posting dates back to February 23rd 2023 and was last modified November 25th 2022. Although no longer recruiting participants, there are still 74 other trials currently searching for volunteers."

Answered by AI

Has NGI226 been officially sanctioned by the FDA?

"There is some evidence available pointing to NGI226's safety profile, consequently it was rated a 2. However, efficacy data has not been collected yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

2023. "A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05592990.