NCT04104867 - 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)

de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium
The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012
Mishima Y, Amano Y, Okita K, Takahashi Y, Moriyama N, Ishimura N, Furuta K, Ishihara S, Adachi K, Kinoshita Y
Efficacy of prokinetic agents in improving bowel preparation for colonoscopy. Digestion. 2008;77(3-4):166-72. doi: 10.1159/000141040. Epub 2008
Panteris V, Haringsma J, Kuipers EJ
Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28. Review.
Pignone M, Saha S, Hoerger T, Mandelblatt J
Cost-effectiveness analyses of colorectal cancer screening: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Jul 16;137(2):96-104. Review.
Quigley EMM
Prokinetics in the Management of Functional Gastrointestinal Disorders. Curr Gastroenterol Rep. 2017 Sep 8;19(10):53. doi: 10.1007/s11894-017-0593-6. Review.

A Randomized Controlled Double-blinded of Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Pre- and Post- Colonoscopy

Clinical trial NCT04104867 - References