Clinical trial NCT01893606: Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Official title: Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: diarrhea
abdominal pain
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 chongqing. 180 IBS-D patients in this research are accord with the Rome III diagnostic criteria, 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. Test cycle includes screening/import period (2 weeks), open treatment period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 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, mucous stool and quality of life parameters (IBS-36 scale). After the end of the treatment period, the participants whose pain intensity and stool type are effective subjects into a randomized withdrawal period, analysis and comparison of the difference between treatment group and placebo group withdrawal rate and curative effect index score reduces.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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;

Primary outcomes:
measure: Abdominal Pain Intensity
timeFrame: one and a half years
measure: Stool Consistency
timeFrame: one and a half years
Secondary outcomes:
measure: General symptoms feel grading
timeFrame: one and a half years
measure: defecation frequency
timeFrame: one and a half years
measure: abdominal distension
timeFrame: one and a half years
measure: mucous stool
timeFrame: one and a half years
measure: life quality parameters
timeFrame: one and a half years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping hospital
state: Chongqing
Study officials:
affiliation: Third MMU
name: Junkang Liu, Doctor
role: STUDY_CHAIR
References: