WHO ICTRP trial
A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase…
EUCTR2019-000796-16-DK · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2019-000796-16-DK |
|---|---|
| Public title | A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis |
| Scientific title | A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis - JTA-KOA2 |
| Primary sponsor | Bone Therapeutics SA |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Czechia;Czech Republic;Hong Kong;Poland;Belgium;Denmark;United Kingdom;Moldova, Republic of |
| Conditions | Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C]… |
| Interventions | Product Name: JTA-004 Product Code: JTA-004 Pharmaceutical Form: Lyophilisate and solvent for solution for injection INN or Proposed INN: Sodium Hyaluronate CAS Number: 9067-32-7 Other descriptive name: SODIUM HYALURONATE Concentration… |
| Registration date | Dec 19, 2019 |
| Target size | 742 |
| Secondary IDs | 000014/BT |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: