Trial · NCT02809105
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
NCT02809105, Phase 3, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation. Trials, record NCT02809105. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02809105
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
- NCT number
- NCT02809105
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 186 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Chronic Constipation
- Interventions
- linaclotide, Placebo
- First posted
- 2016-06-22
- Last updated
- 2024-10-18
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in weekly mean SBM frequency during one week of administration (Part I) | Baseline and Week 1 | SBM: Spontaneous bowel movement |
| Secondary | Change from baseline in weekly mean SBM frequency | Baseline and up to Week 56 | |
| Secondary | Weekly responder rate of SBM | Baseline and up to Week 56 | 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. |
| Secondary | Percentage of subjects with SBM within 24 hours after the start of the initial administration | Up to 24h | |
| Secondary | Time to first SBM | Up to Week 4 | |
| Secondary | Change from baseline in weekly mean CSBM frequency | Baseline and up to Week 56 | CSBM: SBM without a sensation of incomplete evacuation |
| Secondary | Weekly responder rate of CSBM | Baseline and up to Week 56 | 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. |
| Secondary | Percentage of subjects with CSBM within 24 hours after the start of the initial administration | Up to 24h | |
| Secondary | Change from baseline in weekly mean stool form score | Baseline and up to Week 56 | Stool form will be measured using seven-point Bristol Stool Form Scale. |
| Secondary | Change from baseline in weekly mean abdominal bloating severity score | Baseline and up to Week 56 | Abdominal bloating severity will be measured using a five-point ordinal score. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02809105
GET https://conductscience.org/api/trials/v1/NCT02809105/registered