NCT04210427 - 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)

Bentur L, Hino B, Shamir R, Elias N, Hartman C, Eshach-Adiv O, Berkowitz D
Impaired gastric myolectrical activity in patients with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):187-91. doi: 10.1016/j.jcf.2006.03.003. Epub 2006 Apr 19.
Corral JE, Dye CW, Mascarenhas MR, Barkin JS, Salathe M, Moshiree B
Is Gastroparesis Found More Frequently in Patients with Cystic Fibrosis? A Systematic Review. Scientifica (Cairo). 2016;2016:2918139. doi: 10.1155/2016/2918139. Epub 2016 May 30.
Dorsey J, Gonska T
Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine. J Cyst Fibros. 2017 Nov;16 Suppl 2:S14-S23. doi: 10.1016/j.jcf.2017.07.014.
Hedsund C, Gregersen T, Joensson IM, Olesen HV, Krogh K
Gastrointestinal transit times and motility in patients with cystic fibrosis. Scand J Gastroenterol. 2012 Sep;47(8-9):920-6. doi: 10.3109/00365521.2012.699548. Epub 2012 Jul 2.
Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y
Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinic
Schappi MG, Roulet M, Rochat T, Belli DC
Electrogastrography reveals post-prandial gastric dysmotility in children with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):253-6. doi: 10.1097/00005176-200409000-00005.
Xu RB, Bhuyan RR, Edwards JR
Staged Bentall procedure and extra-anatomical repair of coarctation of aorta. ANZ J Surg. 2016 Apr;86(4):310-1. doi: 10.1111/ans.12666. Epub 2014 May 29. No abstract available.

Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit

Details for clinical trial NCT04210427

Clinical trial NCT04210427 - References