ASTELLAS-0456-CL-1031

Study Sponsor: Astellas

Study Title

Phase 3 Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and an Open-label, Uncontrolled, Long-term Dosing Study in Patients with Chronic Constipation (Not Including Constipation Due to Organic Diseases) -

Medicine or Vaccine (generic name)

linaclotide

Sponsor Identification Number

0456-CL-1031

Trial Registry Identification Number(#'s)

NCT02809105

Medical Condition

Chronic constipation

Phase

Phase 3

Link to Astellas Study Register

https://www.clinicaltrials.astellas.com/study/0456-CL-1031

Link to study details on ClinicalTrials.gov (if available)

https://clinicaltrials.gov/ct2/show/NCT02809105

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Synoptic CSR available

Date Added to this Site

February 2020