Letter: placebo run‐in for IBS clinical trials—is it useful?

Abstract

LINKED CONTENTThis article is linked to Hamatani et al papers. To view these articles, visit https://doi.org/10.1111/apt.15907 and https://doi.org/10.1111/apt.16047

Letter: placebo run‐in for IBS clinical trials ‐ is it useful? Authors' reply

“…Second, Bosman et al 1 pointed out that the drop‐out rate during the placebo run‐in period was high (55.7%) in our study 2 . However, the high drop‐out rate was also observed in other phase 3 trials in which investigators confirmed subjects' eligibility for between 2 and 4 weeks before randomisation without use of a placebo (linactotide phase 3: 57%‐59% 4,5 ; plecanatide phase 3: 58%‐63% 6 ; tenapanor phase 3: 61% 7 ).…”

“…Bosman et al 1 compared our results with those of otilonium bromide trials with a placebo run‐in period. However, the endpoints are different in these trials.…”

“…We thank Drs. Bosman and Keszthelyi for their interest and insightful comments 1 on our publication 2 . In our study for irritable bowel syndrome with predominant constipation (IBS‐C), a placebo run‐in period (2 weeks) was set before the treatment period (12 weeks) 2 …”