NCT03295747 - 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)

Shulman RJ, Chumpitazi BP, Abdel-Rahman SM, Garg U, Musaad S, Kearns GL
Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain. Br J Clin Pharmacol. 2022 Mar;88(3):13
Thapa S, Luna RA, Chumpitazi BP, Oezguen N, Abdel-Rahman SM, Garg U, Musaad S, Versalovic J, Kearns GL, Shulman RJ
Peppermint oil effects on the gut microbiome in children with functional abdominal pain. Clin Transl Sci. 2022 Jan 20. doi: 10.1111/cts.132

Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain

Clinical trial NCT03295747 - References