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NCT01858584
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
NA trial testing Gastrotuss in Gastroesophageal Reflux in 75 participants. Status unknown.
1 December 2013
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 February 2013 |
| Primary completion | 1 December 2013 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Gastrotuss — full drug profile →
- thickened milk
Conditions studied
- Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →
- Regurgitation — all drugs for Regurgitation →
- Vomiting — all drugs for Vomiting →
- Chronic Cough — all drugs for Chronic Cough →
Sponsor
Federico II University
Who can join
Under 12 Months, any sex, with Gastroesophageal Reflux or Regurgitation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
efficacy on GER
Time frame: 2 months
This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from RGE the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of GER (I-GERQ Annex A).
Sponsor's own description
The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01858584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroesophageal Reflux
Currently open trials in the same condition.
- NCT07291700 — Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy · recruiting
- NCT06255886 — Treatment of Gastroesophageal Reflux Disease in Infants · Phase 4 · recruiting
- NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06339801 — Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease · recruiting
Other Federico II University trials
Trials by the same sponsor.
- NCT07437690 — Fall Prevention in Older Adults in an Italian Cohort · not yet recruiting
- NCT07282132 — Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter · not yet recruiting
- NCT07280286 — Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel · NA · not yet recruiting
- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · 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 NCT01858584 (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 Federico II University
- Last refreshed: 29 May 2013
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/NCT01858584.
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