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

NCT02809105 | Completed Phase 3

• 1 other identifier: 0456-CL-1031
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 39

Brief Summary

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.

Conditions

Chronic Constipation

Keywords

Chronic constipation; Linaclotide; ASP0456

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weekly mean SBM frequency during one week of administration (Part I)

  SBM: Spontaneous bowel movement

  Baseline and Week 1

Secondary Outcomes (19)

• Change from baseline in weekly mean SBM frequency

  Baseline and up to Week 56

• Weekly responder rate of SBM

  Baseline and up to Week 56

• Percentage of subjects with SBM within 24 hours after the start of the initial administration

  Up to 24h

• Time to first SBM

  Up to Week 4

• Change from baseline in weekly mean CSBM frequency

  Baseline and up to Week 56

Study Arms (3)

Part I ASP0456

EXPERIMENTAL

ASP0456 will be administered orally for 4 weeks.

Drug: linaclotide

Part I Placebo

PLACEBO COMPARATOR

Placebo will be administered orally for 4 weeks.

Drug: Placebo

Part II ASP0456

EXPERIMENTAL

ASP0456 will be administered orally.

Drug: linaclotide

Interventions

linaclotide DRUG

Oral administration once daily

Also known as: ASP0456

Part I ASP0456; Part II ASP0456

Placebo DRUG

Oral administration once daily

Part I Placebo

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with SBM frequency for \< 3 times/week, since ≥ 6 months prior to preliminary enrollment
• Patients with one or more related symptoms for ≥ 6 months prior to preliminary enrollment
• Patients at whom loose (mushy) or watery stools are rarely present without the use of laxatives for ≥ 6 months prior to preliminary enrollment
• Patients who underwent pancolonoscopy or contrast enema after development of the CC symptoms and within 5 years prior to preliminary enrollment, and in whom no organic change was observed which dose not influence on CC symptoms
• Female patients must be either:
• If of non-childbearing potential:
• Post-menopausal at the preliminary enrollment, or documented surgically sterile Or, if of childbearing potential,
• Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
• And have a negative urine pregnancy test at screening
• And, if heterosexually active, agree to consistently use two forms of highly effective birth control throughout the study period and for 28 days after the final study drug administration
• Female patients must agree not to breastfeed throughout the study period and for 28 days after the final study drug administration
• Female patients must not donate ova starting throughout the study period and for 28 days after the final study drug administration
• Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control starting at Screening and continue throughout the study period, and for 28 days after the final study drug administration
• Male subject must not donate sperm starting at Screening and throughout the study period and, for 28 days after the final study drug administration

You may not qualify if:

• Patients who have met the Rome III diagnostic criteria for IBS; with recurrent abdominal pain or discomfort for ≥ 3 days/month in the last 3 months prior to preliminary enrollment, associated with ≥ 2 of the 3 characteristics described below and with the symptoms (IBS symptoms) described above for ≥ 6 months prior to preliminary enrollment
• Improvement with defecation
• Onset associated with a change in frequency of stool
• Onset associated with a change in form (appearance) of stool
• Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine
• Patients with a history or current evidence of inflammatory bowel disease or ischemic colitis
• Patients with concurrent infectious enteritis, hyperthyroidism or hypothyroidism, constipation due to anorectal dysfunction, drug-induced constipation, constipation due to other organic diseases or active peptic ulcer
• Patients with apparent mechanical obstruction
• Patients with megacolon or megarectum
• For female patients, patients with concurrent endometriosis or adenomyosis
• Patients who are considered to have severe depression or a severe anxiety disorder that can affect the efficacy evaluation of the study drug
• Patients with a history of abuse of drugs or alcohol, or current abuse of drugs or alcohol
• Patients who used/underwent or are scheduled to use/undergo prohibited concomitant drugs or therapies, or in whom prohibited examinations were conducted or are scheduled to be conducted 3 days prior to the start of the bowel habit observation period
• Patients with a history or current evidence of malignant tumors
• Patients with concurrent serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal disorders, blood diseases, or neurological/psychiatric diseases

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (39)

Site JP00029

Aichi, Japan

Location

Site JP00030

Aichi, Japan

Location

Site JP00021

Chiba, Japan

Location

Site JP00022

Chiba, Japan

Location

Site JP00023

Chiba, Japan

Location

Site JP00024

Chiba, Japan

Location

Site JP00040

Fukuoka, Japan

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Site JP00001

Hokkaido, Japan

Location

Site JP00002

Hokkaido, Japan

Location

Site JP00037

Hyōgo, Japan

Location

Site JP00038

Hyōgo, Japan

Location

Site JP00039

Hyōgo, Japan

Location

Site JP00017

Kanagawa, Japan

Location

Site JP00018

Kanagawa, Japan

Location

Site JP00019

Kanagawa, Japan

Location

Site JP00020

Kanagawa, Japan

Location

Site JP00031

Osaka, Japan

Location

Site JP00032

Osaka, Japan

Location

Site JP00033

Osaka, Japan

Location

Site JP00034

Osaka, Japan

Location

Site JP00035

Osaka, Japan

Location

Site JP00036

Osaka, Japan

Location

Site JP00025

Saitama, Japan

Location

Site JP00026

Saitama, Japan

Location

Site JP00027

Saitama, Japan

Location

Site JP00028

Saitama, Japan

Location

Site JP00003

Tokyo, Japan

Location

Site JP00004

Tokyo, Japan

Location

Site JP00005

Tokyo, Japan

Location

Site JP00006

Tokyo, Japan

Location

Site JP00007

Tokyo, Japan

Location

Site JP00008

Tokyo, Japan

Location

Site JP00009

Tokyo, Japan

Location

Site JP00010

Tokyo, Japan

Location

Site JP00011

Tokyo, Japan

Location

Site JP00012

Tokyo, Japan

Location

Site JP00013

Tokyo, Japan

Location

Site JP00014

Tokyo, Japan

Location

Site JP00015

Tokyo, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

linaclotide

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: June 24, 2016
• Primary Completion: November 14, 2016
• Study Completion: November 10, 2017
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

JP (39)