NCT04620161

A Proof of Concept Study of Pradigastat in Patients With Functional Constipation

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy, Safety and Tolerability of Pradigastat in Patients With Functional Constipation
Anji Pharma·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Functional Constipation
Drug/Device/Intervention
Pradigastat Tablets 20mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Anji Pharma
Location
Meridian,Evanston,Las Vegas,New York,Mount Pleasant,Beijing,Quanzhou,Guangzhou,Shijiazhuang,Zhengzhou,Wuhan,Changsha,Huai'an,Nanjing,Suzhou,Yangzhou,Pingxiang,Siping,Shanghai,Shanghai,Shanghai,Hangzho, China,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Sep 22, 2020
End date
May 17, 2022
Enrollment
180 participants
Primary outcome

Efficacy of pradigastat in changing the weekly spontaneous bowel movement (SBM) number compared with placebo in patients with functional constipation (FC)

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of
 pradigastat 20 and 40 mg as compared to placebo in patients with Functional Constipation.

ICD-10 classifications
ConstipationOther functional intestinal disordersFunctional intestinal disorder, unspecifiedOther specified functional intestinal disordersOther laxatives
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04620161
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04620161 through Pure Global AI's free database. This Phase 2 trial is sponsored by Anji Pharma and is currently Recruiting. The study focuses on Functional Constipation. Target enrollment is 180 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.