Status:
UNKNOWN
Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Lead Sponsor:
Third Military Medical University
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four centers in chong...
Eligibility Criteria
Inclusion
- 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 or discomfort (hard to describe the discomfort of pain), 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/week.
- Voluntarily signed the informed consent form
Exclusion
- The absorption of any known adverse
- History of gastrointestinal surgery ( not including appendectomy)
- History of organic gastrointestinal diseases: IBS, cancer etc.
- History of chronic diseases: anemia (hemoglobin\<90g/L), pulmonary tuberculosis, diabetes or cardiovascular, liver, kidney, brain, and hematopoietic system and other serious diseases and psychiatric patients, AST(aspartate aminotransferase), ALT (alanine aminotransferase)\> 1.5 times, BUN (blood urea nitrogen)\> 1.2 times, Cr \> 1.0 times normal.
- The disease of lactose intolerance, gallstones, endometriosis, easily confused with IBS symptoms of ;
- Progressive weight loss;
- Concomitant medication is unable to stop but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology;
- Concomitant medication use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as parasympathetic inhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc;
- Other researchers think not suitable for the list;
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01893606
Start Date
April 1 2013
End Date
July 1 2017
Last Update
July 24 2015
Active Locations (1)
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1
Daping hospital
Chongqing, Chongqing Municipality, China, 400038