Skip to content

Trial · Interventional

CompletedPhase 2Registry data

A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

Overview

Status
Completed
Phase
Phase 2
Enrollment
383 participants (actual)
Sponsor
Astellas Pharma Inc · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
13 Apr 2015
Primary completion
31 Oct 2015
Completion
31 Oct 2015
First posted
24 Apr 2015 (estimated)
Last update posted
18 Oct 2024
Conditions
Chronic Constipation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 2

    A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

    NCT02425722

    13 Apr 2015 to 31 Oct 2015

Registry summary

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

The objective of this study is to investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study.

Interventions

  • ASP0456Drug
  • PlaceboDrug

Arms5

  • Experimental

    ASP0456 0.0625mg

    oral

  • Experimental

    ASP0456 0.125mg

    oral

  • Experimental

    ASP0456 0.25mg

    oral

  • Experimental

    ASP0456 0.5mg

    oral

  • Placebo comparator

    Placebo group

    oral

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in weekly average of SBM frequency

    Time frame · From baseline to week 1

    Registry description

    SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7

Secondary outcomes(19)
  1. Weekly responder rate for SBM

    Time frame · up to 2 weeks

    Registry description

    The weekly average 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

  2. Weekly responder rate for CSBM

    Time frame · up to 2 weeks

    Registry description

    The weekly average 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

  3. Percentage of subjects with SBM within 24 hours after the start of initial treatment

    Time frame · up to 24 hours

  4. Change in weekly average of CSBM frequency

    Time frame · From baseline to week 1

  5. Proportion of subjects with CSBM within 24 hours after the start of initial treatment

    Time frame · up to 24 hours

  6. Weekly responder rate of the global assessment of relief of chronic constipation.

    Time frame · up to 2 weeks

    Registry description

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

  7. Weekly responder rate of the abdominal bowel habits improvement in chronic constipation.

    Time frame · up to 2 weeks

    Registry description

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

  8. Weekly responder rate of abdominal symptom relief of chronic constipation.

    Time frame · up to 2 weeks

    Registry description

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

  9. Score of the global assessment of relief of chronic constipation

    Time frame · up to 2 weeks

    Registry description

    Scores will be measured using a seven-point ordinal score

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

    Time frame · Week 0, and 2

    Registry description

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

  11. Changes in weekly average of SBM frequency

    Time frame · From baseline to every week until 2 weeks

    Registry description

    SBM: Spontaneous Bowel Movement

  12. Changes in weekly average of CSBM frequency

    Time frame · From baseline to every week until 2 weeks

    Registry description

    CSBM: Complete Spontaneous Bowel Movement

  13. Changes in weekly average of stool form

    Time frame · From baseline to every week until 2 weeks

    Registry description

    Stool form will be measured using seven-point Bristol Stool Form Scale

  14. Changes in weekly average of abdominal bloating severity scores

    Time frame · From baseline to every week until 2 weeks

    Registry description

    Abdominal bloating severity will be measured using a five-point ordinal score

  15. Changes in weekly average of abdominal pain/discomfort severity scores

    Time frame · From baseline to every week until 2 weeks

    Registry description

    Abdominal pain/discomfort severity will be measured using a five-point ordinal score

  16. Changes in weekly average of straining severity scores

    Time frame · From baseline to every week until 2 weeks

    Registry description

    Straining severity will be measured using a five-point ordinal score

  17. Score of the abdominal bowel habits improvement in chronic constipation

    Time frame · up to 2 weeks

    Registry description

    Scores will be measured using a seven-point ordinal score

  18. Score of the abdominal symptom relief of chronic constipation

    Time frame · up to 2 weeks

    Registry description

    Scores will be measured using a seven-point ordinal score

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

    Time frame · up to 2 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

6 results

Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study.

Fukudo et al. 2018Neurogastroenterology and motilitycited by 10

PMID 30084233DOI 10.1111/nmo.13442PUB-30084233

Free to read · publisher termsCC BY-NC6 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: * Patient who had SBM\* (Spontaneous bowel movement) less than 3 times per week, more than six months prior to the provisional registration * \*Defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation * Patient who was affected with one or more following symptoms before more than six months of provisional registration: * Straining during at least 25% of defecations * Lumpy or hard stools in at least 25% of defecations * Sensation of incomplete evacuation for at least 25% of defecations * Loose stools are rarely present without the use of laxatives more than six months prior to the provisional registration. * Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of chronic constipation symptom and had no organic changes Exclusion Criteria: * Patient who has met IBS-C diagnostic criteria from Rome III more than six months prior to provisional registration. Meaning that patient who had recurrent abdominal pain or discomfort at least 3 days/month in last 3 months associated with two or more of the following, and patient who was affected with following IBS symptoms more than six months prior to the provisional registration: * Improvement with defecation * Onset associated with a change in frequency of stool * Onset associated with a change in form (appearance) of stool * 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 evidence of inflammatory bowel disease (Crohn's disease or ulcerative colitis) * Patient with history or current evidence of ischemic colitis * Patient currently affected by infectious enteritis * Patient currently affected by hyperthyroidism or hypothyroidism * Patient with apparent mechanical obstruction (i.e. patient with ileus caused by hernia) * Patient with mega colon or mega rectum * Patient currently affected by constipation due to anorectal dysfunction * Patient currently affected by drug induced constipation. * Patient with constipation due to other organic disease * Patient currently affected by active peptic ulcer * In the case of a female, 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 (however, patient who used or underwent restricted drug/therapy according to Protocol may be enrolled provisionally) * Patient with history or current evidence of malignant tumor * Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding CC), hemorrhagic disease, or neural/mental disease * Patient with history of drug allergy

PepBank is a research reference. Talk to a doctor before you use any peptide.