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

• ClinicalTrials.gov Identifier: NCT02504060
• Recruitment Status: Unknown
• First Posted: July 21, 2015
• Last Update Posted: July 21, 2015
• Sponsor: Third Military Medical University
• Information provided by (Responsible Party): Liujunkang, Third Military Medical University

Tracking Information

• First Submitted Date: July 16, 2015
• First Posted Date: July 21, 2015
• Last Update Posted Date: July 21, 2015
• Study Start Date: June 2015
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2015)

• Abdominal Pain Intensity [ Time Frame: one and a half years ]
  As measured by numerical rating scale
• Stool Consistency [ Time Frame: one and a half years ]
  As measured by Bristol ' s scale

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 17, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
• Official Title: 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
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Irritable Bowel Syndrome

Intervention

• Drug: Starch Placebo
• Drug: N-acetyl-D-glucosamine
  Other Name: Atysamine(ATSM)

Study Arms

• 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.
  Intervention: 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.
  Intervention: Drug: N-acetyl-D-glucosamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 17, 2015): 720
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02504060
• Other Study ID Numbers: TMMUBC; dongying ( Other Grant/Funding Number: Dongying leader pharmaceutical co.,LTD )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Liujunkang, Third Military Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Third Military Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Junkang Liu, Doctor; Third MMU

• PRS Account: Third Military Medical University
• Verification Date: July 2015