Functional Constipation Clinical Trial
Official title:
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
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.
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. ) ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506801 -
The Effect of Probiotics on Functional Constipation in the Elderly
|
N/A | |
Active, not recruiting |
NCT02361749 -
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
|
Phase 4 | |
Completed |
NCT03054805 -
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
|
Phase 4 | |
Not yet recruiting |
NCT01913665 -
The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation
|
N/A | |
Completed |
NCT01622972 -
Mode of Action of Moviprep
|
Phase 4 | |
Completed |
NCT01348152 -
Effect of TU-100 in Patients With Functional Constipation
|
Phase 2 | |
Completed |
NCT01212146 -
Probiotic-enriched Artichoke in Functional Constipation
|
N/A | |
Completed |
NCT04231162 -
Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation
|
N/A | |
Not yet recruiting |
NCT03639142 -
Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children
|
Phase 3 | |
Recruiting |
NCT04918329 -
Functional Digestive Disorders Observatory
|
||
Completed |
NCT02592200 -
Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women
|
N/A | |
Completed |
NCT03707002 -
Effect of scFOS on Increase in Stool Frequency in Constipated People
|
N/A | |
Recruiting |
NCT06083311 -
The Efficacy of a Probiotic for Functional Constipation (FC)
|
N/A | |
Completed |
NCT04110145 -
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
|
Phase 2 | |
Recruiting |
NCT06196073 -
Visceral Osteopathy in Functional Constipation
|
N/A | |
Completed |
NCT04026113 -
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
|
Phase 3 | |
Completed |
NCT02359396 -
A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01847950 -
Effects of scFOS on Stool Frequency in People With Functionnal Constipation
|
N/A | |
Recruiting |
NCT01274793 -
Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy
|
Phase 1 | |
Active, not recruiting |
NCT04166058 -
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
|
Phase 3 |