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Trial · Interventional

CompletedPhase 3Registry data

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

Overview

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

Japan

Start
24 Jun 2016
Primary completion
14 Nov 2016
Completion
10 Nov 2017
First posted
22 Jun 2016 (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
201620172018
  1. Ph 3

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

    NCT02809105

    24 Jun 2016 to 10 Nov 2017

Registry summary

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

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.

Interventions

  • linaclotideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Part I ASP0456

    ASP0456 will be administered orally for 4 weeks.

  • Placebo comparator

    Part I Placebo

    Placebo will be administered orally for 4 weeks.

  • Experimental

    Part II ASP0456

    ASP0456 will be administered orally.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and Week 1

    Registry description

    SBM: Spontaneous bowel movement

Secondary outcomes(19)
  1. Change from baseline in weekly mean SBM frequency

    Time frame · Baseline and up to Week 56

  2. Weekly responder rate of SBM

    Time frame · Baseline and up to Week 56

    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.

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

    Time frame · Up to 24h

  4. Time to first SBM

    Time frame · Up to Week 4

  5. Change from baseline in weekly mean CSBM frequency

    Time frame · Baseline and up to Week 56

    Registry description

    CSBM: SBM without a sensation of incomplete evacuation

  6. Weekly responder rate of CSBM

    Time frame · Baseline and up to Week 56

    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.

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

    Time frame · Up to 24h

  8. Change from baseline in weekly mean stool form score

    Time frame · Baseline and up to Week 56

    Registry description

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

  9. Change from baseline in weekly mean abdominal bloating severity score

    Time frame · Baseline and up to Week 56

    Registry description

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

  10. Change from baseline in weekly mean abdominal pain/discomfort severity score

    Time frame · Baseline and up to Week 56

    Registry description

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

  11. Change from baseline in weekly mean straining severity score

    Time frame · Baseline and up to Week 56

    Registry description

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

  12. Weekly responder rate of global assessment of relief of CC symptoms

    Time frame · Up to Week 56

    Registry description

    CC: chronic constipation; 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.

  13. Weekly responder rate of abnormal bowel habits improvement in CC

    Time frame · Up to Week 56

    Registry description

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

  14. Weekly responder rate of abdominal symptoms relief of CC

    Time frame · Up to Week 56

    Registry description

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

  15. Change from baseline in IBS-QOL-J score

    Time frame · Baseline and up to Week 56

    Registry description

    IBS-QOL-J: Japanese version of Irritable Bowel Syndrome Quality of Life

  16. Safety assessed by incidence of adverse events

    Time frame · Up to Week 56

  17. Number of participants with abnormal Vital signs and/or adverse events during treatment period

    Time frame · Up to Week 56

  18. Number of participants with abnormal Laboratory values and/or adverse events during treatment period

    Time frame · Up to Week 56

  19. Safety assessed by body weight

    Time frame · Up to Week 56

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

Studies0

Studies that cite this trial.

No study cites this trial.

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 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 Exclusion Criteria: * 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 1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. 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 * Patients with a history of drug allergies * Patients who have participated in the clinical trial of ASP0456 or have been administered ASP0456 * Patients who have participated or are participating in another clinical trial or post-marketing clinical study of other ethical drugs or medical devices within 12 weeks prior to obtaining informed consent

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