NCT01637688 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Burks W, Jones SM, Berseth CL, Harris C, Sampson HA, Scalabrin DM
Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid. J Pediatr. 2008 Aug;153(2):266-71. doi: 10.1016/j.jp
Svasti J, Wasant P, Tiensuwan M, Sawangareetrakul P, Srisomsap C, Pangkanon S, Boonpuan K, Liammongkolkul S
Normal plasma free amino acid levels in Thai children. J Med Assoc Thai. 2001 Nov;84(11):1558-68.

Growth and Plasma Amino Acid Levels in Infants With Cow's Milk Protein Allergy and Treated With a Newly Innovated Amino Acid Formula (NAAF) Compared to a Commercial Amino Acid Formula (AAF)

Details for clinical trial NCT01637688

Clinical trial NCT01637688 - References