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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Anji Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multicenter, randomized, placebo-controlled, double-blind study is designed to demonstrate the efficacy, safety and tolerability of pradigastat relative to placebo across 2 doses (20 and 40 mg) for up to 6 weeks (4-week treatment, 2-week Follow-up) in patients with Functional Constipation. The primary endpoint is the change from baseline in the number of weekly spontaneous bowel movement (SBM), the key secondary endpoint is the change from baseline in the number of weekly complete spontaneous bowel movement (CSBM).An SBM is defined as a stool not induced by rescue medication, whereas a CSBM is defined as an SBM associated with a sensation of complete evacuation. Summary of Protocol Amendments: * Original Protocol: 06 January 2020 * Amendment 1: 30 July 2020 (Reason: To respond Health Authority requests) * Amendment 2: 05 March 2021 (Reason: Sponsor decided to amend the protocol. Key changes: inclusion/exclusion criteria, criteria for Discountinuation from study/Discontinuation from Study Medication, adding the instruction for evaluating and managing diarrhea AEs. )

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	Pradigastat Tablets 20mg	20mg, once daily, oral administration
DRUG	Pradigastat Tablets 40mg	40mg, once daily, oral administration
DRUG	Pradigastat Tablets 20mg matching Placebo	once daily, oral administration
DRUG	Pradigastat Tablets 40mg matching Placebo	once daily, oral administration

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-04-30
• Completion: 2022-06-03
• First posted: 2020-11-06
• Last updated: 2022-08-24

Locations

25 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study