NCT02633592 - 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)

Bharucha AE, Pemberton JH, Locke GR 3rd
American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. Review.
Heinrich H, Fruehauf H, Sauter M, Steingötter A, Fried M, Schwizer W, Fox M
The effect of standard compared to enhanced instruction and verbal feedback on anorectal manometry measurements. Neurogastroenterol Motil. 2013 Mar;25(3):230-7, e163. doi: 10.1111/nmo.12038. Epub 2012 Nov 6.
Noelting J, Ratuapli SK, Bharucha AE, Harvey DM, Ravi K, Zinsmeister AR
Normal values for high-resolution anorectal manometry in healthy women: effects of age and significance of rectoanal gradient. Am J Gastroenterol. 2012 Oct;107(10):1530-6. doi: 10.1038/ajg.2012.221. Epub 2012 Sep 18.
Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR
Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013 Feb;144(2):314-322.e2. doi: 10.1053/j.gastro.2012.10.049. Epub 2012 Nov 7.

Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry: a Randomized Comparison of Measurements in the Seated and Left Lateral Positions

Details for clinical trial NCT02633592

Clinical trial NCT02633592 - References