NCT02504060

Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment

Multicenter Randomized Double-blind Placebo-controlled Clinical Trials to Evaluate the Clinical Efficacy and Safety of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized double-blind placebo-controlled clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment group, 360 for placebo group) in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS(numerical rating scale) week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (12 weeks), follow-up period (2 weeks). The main outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol type), and secondary endpoints included overall symptoms sensory scores, defecation frequency, abdominal distension, defecation urgency and quality of life parameters (IBS-QOL scale).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Starch Placebo
DRUG	N-acetyl-D-glucosamine

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2015-07-21
• Last updated: 2015-07-21

Locations

1 site across 1 country: China