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Trial · Interventional

CompletedPhase 3Registry data

Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Overview

Status
Completed
Phase
Phase 3
Enrollment
500 participants (actual)
Sponsor
Astellas Pharma Inc · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
21 Oct 2014
Primary completion
19 Sept 2015
Completion
29 Mar 2016
First posted
15 Dec 2014 (estimated)
Last update posted
18 Oct 2024
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 3

    Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

    NCT02316899

    21 Oct 2014 to 29 Mar 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).

Interventions

  • linaclotideDrug
  • PlaceboDrug

Arms3

  • Experimental

    ASP0456 (Period I)

    Up to 12 weeks

  • Placebo comparator

    Placebo (Period I)

    Up to 12 weeks

  • Experimental

    ASP0456 (Period II)

    From 12 weeks to 52 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.

    Time frame · During 12 weeks

    Registry description

    The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.

  2. Responder rate of CSBM during 12 weeks

    Time frame · During 12 weeks

    Registry description

    CSBM: Complete Spontaneous Bowel Movement. The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.

Secondary outcomes(13)
  1. Responder rate of SBM during 12 weeks

    Time frame · During 12 weeks

    Registry description

    SBM: Spontaneous Bowel Movement

  2. Responder rate of Abnormal bowel habits improvement during 12 weeks

    Time frame · During 12 weeks

  3. Responder rate of Abdominal pain/discomfort relief during 12 weeks

    Time frame · During 12 weeks

  4. Weekly responder rate of Global assessment of relief of IBS symptoms

    Time frame · Up to 52 weeks

    Registry description

    The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2

  5. Weekly responder rate of CSBM

    Time frame · Up to 52 weeks

    Registry description

    Weekly responder of CSBM: The weekly mean value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period

  6. Weekly responder rate of SBM

    Time frame · Up to 52 weeks

    Registry description

    Weekly responder of SBM: The weekly mean value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period

  7. Weekly responder rate of Abnormal bowel habits improvement

    Time frame · Up to 52 weeks

    Registry description

    Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2

  8. Weekly responder rate of Abdominal pain/discomfort relief

    Time frame · Up to 52 weeks

    Registry description

    Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.

  9. Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity.

    Time frame · From baseline to every week until 52 weeks

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

    Time frame · Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52

    Registry description

    IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version

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

    Time frame · Up to 24 hours

  12. Percentage of subjects with CSBM within 24 hours after start of the initial administration

    Time frame · Up to 24 hours

  13. Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests

    Time frame · Up to 52 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

7 results

A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan.

Fukudo et al. 2018Neurogastroenterology and motilitycited by 27

PMID 30136447DOI 10.1111/nmo.13444PUB-30136447

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * Patient with history of surgical resection of stomach, gallbladder, small intestine, or large intestine (excluding resection of appendicitis and benign polyp) * Patient with history or current affection of inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Patient with history or current affection of ischemic colitis * Patient currently affected by infectious enteritis * Patient currently affected by hyperthyroidism or hypothyroidism * Patient currently affected by active peptic ulcer * In the case of a female patient, the one currently affected by endometriosis or uterine adenomyosis * Patient with high depression or anxiety considered to influence drug evaluation * Patient with history of abuse of drug or alcohol within a year before consent acquisition, or with current abuse * Patient who used or underwent or will use or undergo drug/therapy/test prohibited to combine 3 days before the start of bowel habit observation period (Day -17) or thereafter * Patient with history or current affection of malignant tumor * Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding IBS), hemorrhagic disease, or neural/mental disease * Patient with history of drug allergy

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