AN OPEN‐LABEL, MULTICENTRE STUDY TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL REFLUX SUPPRESSANT (GAVISCON ADVANCE®) IN THE TREATMENT OF HEARTBURN DURING PREGNANCY

Abstract

SUMMARYThis study investigated the efficacy and safety of a novel reflux suppressant, Gaviscon Advance®, in the treatment of heartburn during pregnancy. The study was an open‐label, multicentre, phase IV study in general practice and antenatal clinics in the UK and Republic of South Africa. Pregnant women (≤38 weeks gestation; n=150) aged 18–40 years suffering from heartburn were instructed to take Gaviscon Advance 5–10 ml, as required, to relieve symptoms. The main outcome measures were the efficacy rating of the study medication by the investigator and women after four weeks using a five‐point efficacy scale. After four weeks the investigators' and women's rating of efficacy was ‘very good’ or ‘good’ in 88% and 90% of women, respectively. Most women (57%, n=83) reported symptom relief within 10 minutes. Thus Gaviscon Advance effectively and rapidly treats heartburn during pregnancy. Its use during pregnancy presents no known significant safety concerns for mother or child.