NCT04032652 - 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)

Reissman P, Ehrenpreis ED, Cohen S, Nogueras JJ, Zaitman D, Wexner SD
Electrolyte profiles within the ileoanal pouch: measurement by an in vivo equilibrium dialysis technique. Dig Liver Dis. 2003 Apr;35(4):251-5.
Stobaugh DJ, Deepak P, Thorpe M, Hannon B, Ehrenpreis ED
Simulated comparison of topical and oral formulations of 5-aminosalicylate for the treatment of ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):301-8. doi: 10.1002/ibd.23003.

Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol

Clinical trial NCT04032652 - References