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

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).

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: N-acetyl-D-glucosamine; Drug: Starch Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiaohua Hou, Doctor; Phone Number: 13035143646; Email: yejin8688@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Voluntarily signed the informed consent form.
• Man or woman, aged 18 to 65 years, inclusive.
• Based on the Roman III diagnostic criteria for diagnosis of IBS-D subjects, recurrent abdominal pain accompanied with abdominal discomfort or not, monthly attack within the past 3months at least 3 days. With two or more of the following three kinds of symptoms:

At least a portion of the time abdominal pain or defecate increase when discomfort.

At least a portion of the time abdominal pain or the row of loose stools when discomfort.

At least a portion of the time abdominal pain or discomfort improved after defecation.

Symptoms for at least 6 months before diagnosis.

• Screening/import period pain intensity scores of the NRS 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 per week.
• During the screening period，patients should answer the questions of electronic log completely following the requirements for 10days or more.
• Patients are willing to stop drugs for abdominal symptoms or diarrhea which are in violation of the scheme, and take medicine prescribed in the scheme.
• Patients agree to not change the lifestyle significantly that may affect the symptoms of IBS-D from signing up the Informed Consent Form to the last experiment.
• The illness recured after a normal colonoscopy report within one year that was provided by this hospital or a grade first class teaching hospital, include polyp of colon (less than 3mm,the number of less than 5) patients who taked therapeutic endoscopy and recurrenced within one year; or those that get a normal colonoscopy report in this hospital or a grade first class teaching hospital before screening but have a history of bowel preparation, should be chosen when next attack.

Exclusion Criteria:

• History of organic gastrointestinal diseases: Chronic pancreatitis (cp), inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, gastrointestinal tumor, or other organic diseases etc.
• History of abdominal and pelvic surgery ( not including appendectomy and intestinal polyposis (<3mm) after treatment within one year ).
• The non-intestinal disease of digestive system such as Peptic ulcer, tuberculous peritonitis, cirrhosis etc.
• Heart, lung, kidney and other important organs have severe lesions, immune regulatory disease, metabolic disease (diabetes, thyroid disease) or malignant tumor, reproductive system diseases such as ovarian cysts, endometriosis, etc.
• Laboratory tests or Electrocardiogram were significantly abnormal, and judging by the researchers may damage the patient safety or successful completion of the clinical research:

Male hemoglobin <120g/L, female hemoglobin <100g/L;

Male serum creatinine≥133umol/L, female serum creatinine≥124umol/L; or creatinine clearance rate≤60ml/min;

Chronic liver disease and/or abnormal liver function, defined as AST (aspartate aminotransferase) > 1.5 x ULN (Upper Limit Of Normal) and/or ALT (alanine aminotransferase) > 1.5 x ULN and/or total bilirubin > 1.5x ULN;

• Serious psychiatric patients( Hamilton Depression Scale scores>20).
• History of drug abuse or alcohol abuse.
• Allergic to this study drug.
• Concomitant medication is unable to stop or use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology, parasympathetic inhibitors, muscle relaxants, antidiarrheal, opiates, etc.
• Do not fill in the electronic log of one week before entering the group (-1 week) completely.
• Pregnant or lactating women
• Is participating in clinical trials or have finished it less than 3 months.
• Other researchers think not suitable for the list.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Starch capsule; During the 12- weeks treatment phase of the study, the daily dose of 3 tablets will be taken 30 minutes after breakfast, lunch and supper.	Drug: Starch Placebo
Experimental: N-acetyl-D-glucosamine; During the 12- weeks treatment phase of the study, the daily dose of 100mg*3 (3 tablets) will be taken 30 minutes after breakfast, lunch and supper.	Drug: N-acetyl-D-glucosamine; Other Names: Atysamine(ATSM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Pain Intensity	As measured by numerical rating scale	one and a half years
Stool Consistency	As measured by Bristol ' s scale	one and a half years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General symptoms feel grading	As measure by patient reported outcome measures	one and a half years
defecation frequency	As measure by patient reported outcome measures	one and a half years
abdominal distension	As measure by patient reported outcome measures	one and a half years
life quality parameters	As measure by healthy survey, SF-36	one and a half years
Defecation urgency	As measure by patient reported outcome measures	one and a half years

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Chair: Junkang Liu, Doctor, Third MMU

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: diarrhea; abdominal pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: TMMUBC; dongying (Other Grant/Funding Number: Dongying leader pharmaceutical co.,LTD)