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New thickened formula · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| New thickened infant formula | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| New thickened formula | DIETARY_SUPPLEMENT | - |
Inclusion Criteria: Infants : * Aged ≤ 5 months old * fully formula fed * with at least 5 episodes of regurgitation per day Exclusion Criteria: * Breast fed infants * Infants presenting symptoms of a complicated gastroesophageal reflux * Infants presenting intestinal disorders
New thickened formula is an investigational product being studied for the management of gastroesophageal reflux. It is intended to help reduce regurgitation in affected individuals. The product is currently in clinical development and has not been approved by regulatory authorities.
New thickened formula is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the product's safety and efficacy for gastroesophageal reflux.
New thickened formula is in Phase 3 clinical development. It is an investigational product and has not yet received regulatory approval. The Phase 3 trial has been completed, and the product remains under evaluation for its intended use in gastroesophageal reflux.
New thickened formula has been studied in one completed Phase 3 clinical trial with the identifier NCT02425423. The trial, titled 'Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula,' enrolled 100 participants and was conducted in Belgium and France.
New thickened formula is not FDA approved. It is an investigational product currently in clinical development. A Phase 3 trial has been completed, but the product has not yet received marketing authorization from regulatory agencies.