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NCT02442752
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
Phase 1 trial testing Dexlansoprazole in Pediatric Gastroesophageal Reflux Disease. Withdrawn.
23 December 2025
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 15 June 2025 |
| Primary completion | 23 December 2025 |
| Estimated completion | 23 December 2025 |
| Sites | 22 locations across Italy, Israel, Poland, Mexico, United States |
Drugs / interventions tested
- Dexlansoprazole (DEXLANSOPRAZOLE) — full drug profile →
Conditions studied
- Pediatric Gastroesophageal Reflux Disease — all drugs for Pediatric Gastroesophageal Reflux Disease →
Sponsor
Takeda — full company profile →
Who can join
Adults 1 Month to 11 Months, any sex, with Pediatric Gastroesophageal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) \[after daily administration for 7 days\] and safety \[after daily administration for 8 weeks\] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02442752
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dexlansoprazole
Trials testing the same drug.
- NCT02615184 — A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in C · Phase 2 · active not recruiting
- NCT02616302 — A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux · Phase 2 · recruiting
- NCT04877834 — Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Heal · Phase 1 · completed
- NCT03316976 — A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Heal · Phase 1 · completed
- NCT02873689 — Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients · Phase 3 · completed
Other Takeda trials
Trials by the same sponsor.
- NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
- NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
- NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
- NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
- NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02442752 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 15 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02442752.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing