Trial · NCT04620161
A Proof of Concept Study of Pradigastat in Patients With Functional Constipation
NCT04620161, Phase 2, Completed, Anji Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Proof of Concept Study of Pradigastat in Patients With Functional Constipation. Trials, record NCT04620161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04620161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof of Concept Study of Pradigastat in Patients With Functional Constipation
- NCT number
- NCT04620161
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Anji Pharma
- Conditions
- Functional Constipation
- Interventions
- Pradigastat Tablets 20mg, Pradigastat Tablets 40mg, Pradigastat Tablets 20mg matching Placebo, Pradigastat Tablets 40mg matching Placebo
- First posted
- 2020-11-06
- Last updated
- 2022-08-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of pradigastat in changing the weekly spontaneous bowel movement (SBM) number compared with placebo in patients with functional constipation (FC) | Week 4 | Number change from baseline in the weekly SBM at Week 4 |
| Secondary | Efficacy of pradigastat in changing the weekly complete spontaneous bowel movement (CSBM) number compared with placebo in patients with FC | Week 4 | Number change from baseline in the weekly CSBM at Week 4 |
| Secondary | Safety assessed by incidence of Adverse Events | Each visit through Week 4 | Safety assessed by incidence of Adverse Events |
| Secondary | Efficacy of pradigastat in changing the responder rate compared with placebo in patients with FC | From baseline to every week until Week 4 | Weekly response rate for SBM |
| Secondary | Change in weekly score for overall assessment of constipation symptoms and accompanied GI symptoms | From baseline to every week until Week 4 | Change in weekly score for overall assessment of constipation symptoms and accompanied GI symptoms (Weekly score includes 10 questions with the range of the total score from 10 to 68, and lower scores mean a better outcome.) |
| Secondary | Trough pradigastat plasma concentrations | Week 1 and Week 4 | Mean plasma pradigastat concentration |
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/NCT04620161
GET https://conductscience.org/api/trials/v1/NCT04620161/registered