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

NCT02504060 | Unknown Phase 3 DMC

• 2 other identifiers: TMMUBCdongying
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome

Keywords

diarrhea; abdominal pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

Starch capsule

PLACEBO COMPARATOR

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

N-acetyl-D-glucosamine

EXPERIMENTAL

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

Interventions

Starch Placebo DRUG

Starch capsule

N-acetyl-D-glucosamine DRUG

Also known as: Atysamine(ATSM)

N-acetyl-D-glucosamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Abdominal Pain

Interventions

Acetylglucosamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Glucosamine; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Junkang Liu, Doctor

  Third MMU

  STUDY CHAIR

Central Study Contacts

Junkang Liu, Doctor

CONTACT

+86-023-68752191; liujunkang@163.com

Yanxia Liu, Master

CONTACT

+86-023-68752372; liuyibin_04@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of microecological pharmaceutical research

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 21, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

CN (1)