Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study is to evaluate the improvement in the severity of constipation (from Baseline to Day 28), determined by the constipation severity instrument (CSI) score [1], compared to placebo, following a total daily oral dose of 15 g TU-100 administered for 28 consecutive days in adult subjects with functional constipation.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01348152
Study type Interventional
Source Tsumura USA
Contact
Status Completed
Phase Phase 2
Start date September 2011
Completion date July 2013

See also
  Status Clinical Trial Phase
Completed NCT04506801 - The Effect of Probiotics on Functional Constipation in the Elderly N/A
Completed NCT04620161 - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation Phase 2
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 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
Active, not recruiting 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
Enrolling by invitation NCT04166058 - Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Phase 3