NCT02431533 - 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)

Dolin BJ
Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.
Drossman DA
Review article: an integrated approach to the irritable bowel syndrome. Aliment Pharmacol Ther. 1999 May;13 Suppl 2:3-14. Review.
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC
Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. Review. Erratum in: Gastroenterology. 2006 Aug;131(2):688.
Longstreth GF, Wilson A, Knight K, Wong J, Chiou CF, Barghout V, Frech F, Ofman JJ
Irritable bowel syndrome, health care use, and costs: a U.S. managed care perspective. Am J Gastroenterol. 2003 Mar;98(3):600-7.
Schoenfeld P, Talley NJ
Measuring successful treatment of irritable bowel syndrome: is "satisfactory relief " enough? Am J Gastroenterol. 2006 May;101(5):1066-8.

The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome: A Randomized, Double-Blind Placebo Controlled Clinical Trial

Clinical trial NCT02431533 - References