A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation.

"Guarantor of the article: William D. Chey, MD, AGAF, FACG, FACP.: Specific author contributions: Full access to all the data in the study and took responsibility for the integrity of the data and the accuracy of the data analyses and wrote the first draft of the manuscript: William D. Chey and Hans Graffner. No professional writing assistance was utilized in the preparation of this manuscript. All authors contributed to study concept and design and data analyses, drafted and reviewed the manuscript revisions, and approved the final draft for submission. The statistical analysis of the entire data sets has been independently analyzed by a biostatistician not employed by Albireo and with no links to the institution performing the study.: Financial support: Albireo funded this study and provided A3309.: Potential competing interests: Rikner and Graffner are employees of Albireo. Chey is a consultant for Albireo. Camilleri receives a research grant from Albireo, and serves as a consultant for Albireo with payment of consultant fee to Mayo Clinic. Chang serves as a consultant for Albireo."

"Financial support: Albireo funded this study and provided A3309."

"A randomized, double-blind, placebo-controlled study was conducted at 45 sites across the United States between November 2009 (first signed informed consent) and August 2010 (last patient visit). The study was conducted in accordance with the Declaration of Helsinki and with Good Clinical Practice guidelines. Written informed consent was obtained from all patients before participation. Central or local Ethical Review Boards approved the study protocol and the informed consent form. The study was registered on ClinicalTrial.Gov [NCT01007123]. Treatment allocation and concealment were conducted by a computerized random-number generator and numbered containers with active and placebo capsules of identical appearance. The randomization list was centrally held by an independent Contract Research Organization, all randomized patients and study center and contract research organization personnel were blinded to study treatment allocation until data were locked and analyzed."