Current partner codePEPTIDESDE
NCT01714843·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

559

Locations

4

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

linaclotide

oral

DRUG

placebo

oral

Timeline

From registration to results.

  1. First posted

    Oct 26, 2012

  2. Study start

    Aug 10, 2012

  3. Primary completion

    Dec 7, 2013

  4. Study completion

    Dec 7, 2013

  5. Results posted

    Not reported

  6. Registry updated

    Oct 18, 2024

Outcomes

What the study measures.

Primary outcomes

Global assessment of relief of IBS symptoms Responder

Time frame · Weekly for 12 weeks

Secondary outcomes

SBM (Spontaneous Bowel Movement) Responder

Time frame · Weekly for 12 weeks

CSBM (Complete SBM) Responder

Time frame · Weekly for 12 weeks

Abnormal bowel habits improvement Responder

Time frame · Weekly for 12 weeks

Abdominal pain/discomfort relief Responder

Time frame · Weekly for 12 weeks

Changes in weekly average of SBM frequency

Time frame · Weekly for 12 weeks

Changes in weekly average of CSBM frequency

Time frame · Weekly for 12 weeks

Changes in weekly average of stool form scores

Time frame · Weekly for 12 weeks

Changes in weekly average of abdominal pain/discomfort severity

Time frame · Weekly for 12 weeks

Changes in weekly average of straining severity

Time frame · Weekly for 12 weeks

Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)

Time frame · Weekly for 12 weeks

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

4 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Hokkaido, Japan

Facility not named

Kansai, Japan

Facility not named

Kantou, Japan

Facility not named

Kyusyu, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Linaclotide.

Related PeptideStat pages

Put the record in context.

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