NCT02809105 is a Phase 3 clinical trial of linaclotide in Chronic Constipation, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT02809105?

NCT02809105 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT02809105?

Interventions in NCT02809105: linaclotide, Placebo.

What condition does NCT02809105 study?

NCT02809105 studies Chronic Constipation.

Is NCT02809105 still recruiting?

NCT02809105 is currently completed. Last updated 18 October 2024.

Last reviewed 2024-10-18 · How we verify

NCT02809105

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation

Completed Phase 3 Last updated 18 October 2024

What this trial tests

Phase 3 trial testing linaclotide in Chronic Constipation in 186 participants. Completed in 10 November 2017.

Timeline

24 June 2016

Primary endpoint
14 November 2016

10 November 2017

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	186
Start date	24 June 2016
Primary completion	14 November 2016
Estimated completion	10 November 2017
Sites	39 locations across Japan

Drugs / interventions tested

linaclotide (LINACLOTIDE) — full drug profile →
Placebo

Conditions studied

Chronic Constipation — all drugs for Chronic Constipation →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 20 to 79, any sex, with Chronic Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to verify the efficacy and investigate the safety of the study drug when ASP0456 is administered orally for 4 weeks and 52 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

High-dose linaclotide is effective and safe in patients with chronic constipation: A phase III randomized, double-blind, placebo-controlled study with a long-term open-label extension study in Japan.
Fukudo S, Miwa H, Nakajima A, Kinoshita Y, et al · · 2019 · cited 31× · PMID 30353619 · DOI 10.1111/nmo.13487
Decoding signaling mechanisms: unraveling the targets of guanylate cyclase agonists in cardiovascular and digestive diseases.
Yin Q, Zheng X, Song Y, Wu L, et al · · 2023 · cited 3× · PMID 38186653 · DOI 10.3389/fphar.2023.1272073

Verify or expand the search:

Other trials of linaclotide

Trials testing the same drug.

NCT03471728 — Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic · completed
NCT02316899 — Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel · Phase 3 · completed
NCT02220348 — A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically · Phase 1 · completed
NCT01714843 — A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome · Phase 2 · completed

Other recruiting trials for Chronic Constipation

Currently open trials in the same condition.

NCT07387952 — The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of F · NA · recruiting
NCT06911749 — MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders · NA · recruiting
NCT06847919 — Exploring the Potential Benefits of Probiotic Yogurt · NA · recruiting
NCT06543979 — Anorectal Manometery in Pediatric Chronic Refractory Constipation · Phase 1, PHASE2 · recruiting
NCT03819062 — Sacral Neuromodulation as Treatment for Chronic Constipation · NA · recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02809105 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 18 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02809105.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing