Abstract
Reply to: Johnston JM, Schneier HA. Clarification of trial end points presented in a recent review of linaclotide. Expert Rev. Gastroenterol. Hepatol. 6(1), 13–14 (2012).
We want to thank Drs Johnston and Schneier from Ironwood Pharmaceuticals (Cambridge, MA, USA) and Forest Laboratories (New York, NY, USA), respectively, for their letter and clarification regarding the end points of the most recent Phase III clinical trials of linaclotide and irritable bowel syndrome (IBS). We appreciate that these Phase III trials in IBS with constipation (IBS-C) patients had a total of four primary end points, and had indicated this in Table 1 of our article (see the summary on Brady et al., reference 103, in the review article pertaining to the company’s press release). We also recognize that the fourth end point (US FDA draft guidance end point) in the table erroneously included ≥3 complete spontaneous bowel movements, which was included in other composite end points. At the time of writing the review, we were limited to data available in abstract form or press releases and to the information available on ClinicalTrials.gov pertaining to NCT00938717 and NCT00948818. Neither of the two registrations in ClinicalTrials.gov reported four end points in the two IBS-C trials. We are looking forward to the full articles of these two comprehensive studies in IBS-C so that all readers can have access to the information about the trial end points.
Disclaimer
This work is the opinion of the authors and does not represent the views of Expert Reviews Ltd or its employees.
Financial & competing interests disclosure
M Camilleri has consulted for Ironwood Pharmaceuticals regarding linaclotide. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.