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

NCT04620161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Anji Pharma

    lead INDUSTRY

Principal Investigators

  • Dan Meyers, M.D. · Anji Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2022-04-30
Completion
2022-06-03
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620161 on ClinicalTrials.gov