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A Proof of Concept Study of Pradigastat in Patients With Functional Constipation - Trial NCT04620161

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.

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NCT04620161
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT04620161
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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

Study Focus

Functional Constipation

Pradigastat Tablets 20mg

Interventional

drug

Sponsor & Location

Anji Pharma

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 2

Sep 22, 2020

May 17, 2022

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

Constipation
Other functional intestinal disorders
Functional intestinal disorder, unspecified
Other specified functional intestinal disorders
Other laxatives

Data Source

ClinicalTrials.gov

NCT04620161

Non-Device Trial