Trials Sponsors Conditions Drugs Pricing

Conditions

Achilles Tendinopathy

Keywords

Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection

Outcome Measures

Primary Outcomes (1)

Number of participants with AEs and SAEs
AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability
Up to Day 169 (End of Study)

Secondary Outcomes (1)

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

Study Arms (2)

NGI226

EXPERIMENTAL

single peritendon injection

Drug: NGI226

Placebo

PLACEBO COMPARATOR

single peritendon injection

Drug: Placebo

Interventions

NGI226Drug

NGI226 MP

NGI226

PlaceboDrug

Placebo MP

Placebo

Eligibility Criteria

Age30 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible.
Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms present ≥8 weeks but \<12 months at screening.

Sponsors & Collaborators

Novartis Pharma AG
Industrylead
Novartis Pharmaceuticals
Industrylead

Study Sites (7)

Tucson Orthopedic Institute PC

Tucson, Arizona, 85712, United States

Advanced Research LLC

Deerfield Beach, Florida, 33064, United States

Houston Methodist Hospital

Houston, Texas, 77030, United States

Novartis Investigative Site

Caluire-et-Cuire, 69300, France

Novartis Investigative Site

Berlin, 10117, Germany

Novartis Investigative Site

Hamburg, 20149, Germany

Novartis Investigative Site

Hamburg, 22415, Germany

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

June 14, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

NGI226

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

NGI226

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations