NCT02470117 - 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)

Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW
Alginate rafts and their characterisation. Int J Pharm. 2005 Apr 27;294(1-2):137-47.
Katz PO, Gerson LB, Vela MF
Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. Erratum in: Am J Gastroenterol. 2013 Oct;108(10):1672.
Mahadevan U, Kane S
American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review.
Malmud LS, Charkes ND, Littlefield J, Reilley J, Stern H, Rosenberg R, Fisher RS
The mode of action alginic acid compound in the reduction of gastroesophageal reflux. J Nucl Med. 1979 Oct;20(10):1023-8.
Quartarone G
Gastroesophageal reflux in pregnancy: a systematic review on the benefit of raft forming agents. Minerva Ginecol. 2013 Oct;65(5):541-9. Review.
Richter JE
Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005 Nov 1;22(9):749-57. Review.
Strugala V, Bassin J, Swales VS, Lindow SW, Dettmar PW, Thomas EC
Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy. ISRN Obstet Gynecol. 2012;2012:481870

Comparison of the Efficacy of Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy : A Randomized Double-Blind Controlled Trial

Details for clinical trial NCT02470117

Clinical trial NCT02470117 - References