Trial · NCT02425722
A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation
NCT02425722, Phase 2, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation. Trials, record NCT02425722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02425722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation
- NCT number
- NCT02425722
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 383 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Chronic Constipation
- Interventions
- ASP0456, Placebo
- First posted
- 2015-04-24
- 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 in weekly average of SBM frequency | From baseline to week 1 | 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 | Weekly responder rate for SBM | up to 2 weeks | 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 | Weekly responder rate for CSBM | up to 2 weeks | 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 SBM within 24 hours after the start of initial treatment | up to 24 hours | |
| Secondary | Change in weekly average of CSBM frequency | From baseline to week 1 | |
| Secondary | Proportion of subjects with CSBM within 24 hours after the start of initial treatment | up to 24 hours | |
| Secondary | Weekly responder rate of the global assessment of relief of chronic constipation. | up to 2 weeks | 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 |
| Secondary | Weekly responder rate of the abdominal bowel habits improvement in chronic constipation. | up to 2 weeks | Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2 |
| Secondary | Weekly responder rate of abdominal symptom relief of chronic constipation. | up to 2 weeks | Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2 |
| Secondary | Score of the global assessment of relief of chronic constipation | up to 2 weeks | Scores will be measured using a seven-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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30084233 | DERIVED |
Source PubMed
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/NCT02425722
GET https://conductscience.org/api/trials/v1/NCT02425722/registered