NCT00419549 - 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)

Cheng CL, Sherman S, Watkins JL, Barnett J, Freeman M, Geenen J, Ryan M, Parker H, Frakes JT, Fogel EL, Silverman WB, Dua KS, Aliperti G, Yakshe P, Uzer M, Jones W, Goff J, Lazzell-Pannell L, Rashdan A, Temkit M, Lehman GA
Risk factors for post-ERCP pancreatitis: a prospective multicenter study. Am J Gastroenterol. 2006 Jan;101(1):139-47.
Freeman ML, Guda NM
Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. Review.
Kaffes AJ, Bourke MJ, Ding S, Alrubaie A, Kwan V, Williams SJ
A prospective, randomized, placebo-controlled trial of transdermal glyceryl trinitrate in ERCP: effects on technical success and post-ERCP pancreatitis. Gastrointest Endosc. 2006 Sep;64(3):351-7. Epub 2006 May 19.
Moretó M, Zaballa M, Casado I, Merino O, Rueda M, Ramírez K, Urcelay R, Baranda A
Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7.

Effect of Transdermal Glyceryl-Trinitrate and Parecoxib (Valdecoxib) for the Prevention of Post -ERCP Pancreatitis

Clinical trial NCT00419549 - References