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

Irritable Bowel Syndrome Clinical Trial

Official title:

Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893606
• Other study ID #: liujunkang
• Secondary ID: dongying
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 6, 2013
• Last updated: July 23, 2015
• Start date: April 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2015
• Source: Third Military Medical University
• Contact: Junkang Liu, Doctor
• Phone: +86-023-68752191
• Email: liujunkang[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• N-acetyl-D-glucosamine

• placebo

Locations

Country	Name	City	State
China	Daping hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Pain Intensity	As measured by numerical rating scale	one and a half years	Yes
Primary	Stool Consistency	As measured by Bristol ' s scale	one and a half years	Yes
Secondary	General symptoms feel grading	As measure by patient reported outcome measures	one and a half years	Yes
Secondary	defecation frequency	As measure by patient reported outcome measures	one and a half years	Yes
Secondary	abdominal distension	As measure by patient reported outcome measures	one and a half years	Yes
Secondary	mucous stool	As measure by patient reported outcome measures	one and a half years	Yes
Secondary	life quality parameters	As measure by healthy survey, SF-36	one and a half years	Yes