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Lipase Inhibitor

Pradigastat Tablets 40mg for Constipation

Phase 2
Waitlist Available
Research Sponsored by Anji Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 and week 4

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.

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of pradigastat in changing the weekly spontaneous bowel movement (SBM) number compared with placebo in patients with functional constipation (FC)
Secondary study objectives
Change in weekly score for overall assessment of constipation symptoms and accompanied GI symptoms
Efficacy of pradigastat in changing the responder rate compared with placebo in patients with FC
Efficacy of pradigastat in changing the weekly complete spontaneous bowel movement (CSBM) number compared with placebo in patients with FC
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pradigastat Tablets 40mgExperimental Treatment2 Interventions
The patients in this arm will receive one tablet a day of Pradigastat 40mg and one tablet a day of Pradigastat 20mg matching placebo
Group II: Pradigastat Tablets 20mgExperimental Treatment2 Interventions
The patients in this arm will receive one tablet a day of Pradigastat 20mg and one tablet a day of Pradigastat 40mg matching placebo
Group III: PlaceboPlacebo Group2 Interventions
The patients in this arm will receive one tablet a day of Pradigastat 20mg matching placebo and one tablet a day of Pradigastat 40mg matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pradigastat Tablets 20mg
2020
Completed Phase 2
~190
Pradigastat Tablets 40mg matching Placebo
2020
Completed Phase 2
~190
Pradigastat Tablets 40mg
2020
Completed Phase 2
~190
Pradigastat Tablets 20mg matching Placebo
2020
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Anji PharmaLead Sponsor
2 Previous Clinical Trials
693 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,637 Total Patients Enrolled
Dan Meyers, M.D.Study ChairAnji Pharma
~35 spots leftby Nov 2025
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