WHO ICTRP trial
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in…
EUCTR2014-001642-16-PL · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-001642-16-PL |
|---|---|
| Public title | Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months |
| Scientific title | A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases |
| Primary sponsor | Takeda Development Centre Europe Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Mexico;Poland;Israel;Italy |
| Conditions | Acid-Related Disorders in Infants aged 1 to 11 months MedDRA version: 17.1 Level: LLT Classification code 10066874 Term: Gastroesophageal reflux disease System Organ Class: 100000004856 MedDRA version: 17.1 Level: LLT Classification code… |
| Interventions | Trade Name: Dexlansoprazole Delayed-Release Capsules Product Name: Dexlansoprazole Delayed-Release Capsules Product Code: TAK-390MR Pharmaceutical Form: Capsule INN or Proposed INN: Dexlansoprazole CAS Number: 138530-94-6 Other descriptive… |
| Registration date | Feb 20, 2015 |
| Target size | 24 |
| Secondary IDs | TAK-390MR_108;2014-001642-16-IT |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: