WHO ICTRP trial
Clinical study to show if Naronapride tablets are safe and efficient for…
EUCTR2021-002254-86-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-002254-86-DE |
|---|---|
| Public title | Clinical study to show if Naronapride tablets are safe and efficient for treatment of delayed stomach emptying and to find the optimal dose |
| Scientific title | Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis |
| Primary sponsor | Dr. Falk Pharma GmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Austria;Latvia;Netherlands;Belgium;United States;Poland;United Kingdom;Italy;Australia;France;Switzerland;Germany |
| Conditions | idiopathic or diabetic gastroparesis MedDRA version: 20.1 Level: PT Classification code 10051153 Term: Diabetic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code… |
| Interventions | Product Name: Naronapride 10 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Naronapride dihydrochloride trihydrate Current Sponsor code: ATI-7505 Concentration unit: mg milligram(s) Concentration type… |
| Registration date | Oct 5, 2022 |
| Target size | 320 |
| Secondary IDs | NAT-19/GPX;MOVE-IT |
| 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: