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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504060
Recruitment Status : Unknown
Verified July 2015 by Liujunkang, Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Liujunkang, Third Military Medical University

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Starch Placebo Drug: N-acetyl-D-glucosamine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: 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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


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 Name: Atysamine(ATSM)




Primary Outcome Measures :
  1. Abdominal Pain Intensity [ Time Frame: one and a half years ]
    As measured by numerical rating scale

  2. Stool Consistency [ Time Frame: one and a half years ]
    As measured by Bristol ' s scale


Secondary Outcome Measures :
  1. General symptoms feel grading [ Time Frame: one and a half years ]
    As measure by patient reported outcome measures

  2. defecation frequency [ Time Frame: one and a half years ]
    As measure by patient reported outcome measures

  3. abdominal distension [ Time Frame: one and a half years ]
    As measure by patient reported outcome measures

  4. Defecation urgency [ Time Frame: one and a half years ]
    As measure by patient reported outcome measures

  5. life quality parameters [ Time Frame: one and a half years ]
    As measure by healthy survey, SF-36



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504060


Contacts
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Contact: Junkang Liu, Doctor +86-023-68752191 liujunkang@163.com
Contact: Yanxia Liu, Master +86-023-68752372 liuyibin_04@163.com

Locations
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China, Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaohua Hou, Doctor    13035143646    yejin8688@sina.com   
Sponsors and Collaborators
Third Military Medical University
Investigators
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Study Chair: Junkang Liu, Doctor Third MMU
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Responsible Party: Liujunkang, The director of microecological pharmaceutical research, Third Military Medical University
ClinicalTrials.gov Identifier: NCT02504060    
Other Study ID Numbers: TMMUBC
dongying ( Other Grant/Funding Number: Dongying leader pharmaceutical co.,LTD )
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Keywords provided by Liujunkang, Third Military Medical University:
diarrhea
abdominal pain
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases