A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-10

Study Completion Date

2013-12-07

Brief Summary

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This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.

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Detailed Description

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This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.

Conditions

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Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

oral

Interventions

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linaclotide

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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ASP0456

Eligibility Criteria

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Inclusion Criteria

* Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period.
* Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and \<25% of them loose (mushy) or watery during the 3 months before the screening examination.
* Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes.

Exclusion Criteria

* Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
* Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
* Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
* Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No