NCT04671264 - 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)

Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R
Bowel Disorders. Gastroenterology. 2016 Feb 18. pii: S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. [Epub ahead of print]
Nee J, Sugarman MA, Ballou S, Katon J, Rangan V, Singh P, Zubiago J, Kaptchuk TJ, Lembo A
Placebo Response in Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Dec;114(12):1838-1846. doi: 10.14309/ajg.0000000000000399.
Nelson AD, Camilleri M, Acosta A, Boldingh A, Busciglio I, Burton D, Ryks M, Zinsmeister AR
A single-center, prospective, double-blind, sham-controlled, randomized study of the effect of a vibrating capsule on colonic transit in patients with chronic constipation. Neurogastroenterol Motil. 2017 Jul;29(7). doi: 10.1111/nmo.13034. Epub 2017 Feb 8.
Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD
Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
Suares NC, Ford AC
Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24. Review.
Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS
Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.

Efficacy and Safety of Vibrating Capsule in the Treatment of Functional Constipation: a Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study

Details for clinical trial NCT04671264

Clinical trial NCT04671264 - References