Trial · Interventional
CompletedPhase 3Registry dataA 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
- Ph 3
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
NCT0280910524 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.
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)
Change from baseline in weekly mean SBM frequency
Time frame · Baseline and up to Week 56
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.
Percentage of subjects with SBM within 24 hours after the start of the initial administration
Time frame · Up to 24h
Time to first SBM
Time frame · Up to Week 4
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
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.
Percentage of subjects with CSBM within 24 hours after the start of the initial administration
Time frame · Up to 24h
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.
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.
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.
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.
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.
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.
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.
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
Safety assessed by incidence of adverse events
Time frame · Up to Week 56
Number of participants with abnormal Vital signs and/or adverse events during treatment period
Time frame · Up to Week 56
Number of participants with abnormal Laboratory values and/or adverse events during treatment period
Time frame · Up to Week 56
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
PepBank is a research reference. Talk to a doctor before you use any peptide.