MedTrace Logo

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

NCT02504060 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2015-07-21

No results posted yet for this study

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

DRUG

Starch Placebo

DRUG

N-acetyl-D-glucosamine

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Junkang Liu, Doctor · Third MMU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2017-07-31

Countries

  • China

Study Locations

More Related Trials

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 NCT02504060 on ClinicalTrials.gov