The maker of a leading over-the-counter antacid has withdrawn its application for approval of the drug in China because a clinical trial of the product in that country was marred by “major protocol deviations.”
Researchers for the company, Reckitt Benckiser, maker of Gaviscon, had published a report on the study in 2015 in the journal Alimentary Pharmacology & Therapeutics. But the journal has now retracted the article, “Randomised clinical trial: The clinical efficacy and safety of an alginate‐antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China,” at the behest of the drug maker.
According to the notice: Continue reading “Sufficiently serious” issues in study prompt company to yank drug approval application in China
A gastroenterology and hepatology journal has retracted a 2017 review after discovering it included data “accessible only during peer review for another journal.”