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
Overview
- Phase
- Phase 3
- Intervention
- Starch Placebo
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Third Military Medical University
- Enrollment
- 720
- Locations
- 1
- Primary Endpoint
- Abdominal Pain Intensity
- Last Updated
- 10 years ago
Overview
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).
Investigators
Liujunkang
The director of microecological pharmaceutical research
Third Military Medical University
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.
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.
Arms & Interventions
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: Starch Placebo
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: N-acetyl-D-glucosamine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- General symptoms feel grading(one and a half years)
- defecation frequency(one and a half years)
- abdominal distension(one and a half years)
- Defecation urgency(one and a half years)
- life quality parameters(one and a half years)