Trial · NCT03471728
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
NCT03471728, Completed, Astellas Pharma Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases). Trials, record NCT03471728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03471728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
- NCT number
- NCT03471728
- Status
- Completed
- Enrollment
- 2,475 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases), Irritable Bowel Syndrome With Constipation (IBS-C)
- Interventions
- linaclotide
- First posted
- 2018-03-21
- Last updated
- 2024-10-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of diarrhea | Up to Week 36 | To assess the incidence of diarrhea as a criteria of safety variables. |
| Secondary | Safety assessed by incidence of adverse drug reactions | Up to Week 36 | Adverse drug reactions will be coded using Medical Dictionary for Regulatory Activities (MedDRA). |
| Secondary | Efficacy assessed by Global assessment of relief of IBS and constipation symptoms | Up to Week 36 | Global assessment of relief of IBS and constipation symptoms will be evaluated based on the clinical course in a medical interview with the patient and evaluate efficacy using a 7-point scale: 1: much better; 2: better; 3: a little better; 4: no change; 5: a little worse; 6: worse; 7: much worse. If the evaluation is impossible, a reason will be provided. |
Source ClinicalTrials.gov
Outcomes0
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/NCT03471728
GET https://conductscience.org/api/trials/v1/NCT03471728/registered