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

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

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.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: placebo; Drug: N-acetyl-D-glucosamine

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Junkang Liu, Doctor; Phone Number: +86-023-68752191; Email: liujunkang@163.com
• Study Contact Backup: Name: Yanxia Liu, Master; Phone Number: +86-023-68752190; Email: liuyibin_04@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Daping Hospital
      • Contact: Dongfeng Chen, doctor; Phone Number: 13883032812

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Starch capsule; During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper.	Drug: placebo
Experimental: N-acetyl-D-glucosamine; During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken.	Drug: N-acetyl-D-glucosamine; Other Names: Atysamine (ATSM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
General symptoms feel grading	As measure by patient reported outcome measures	one and a half years
defecation frequency	As measure by patient reported outcome measures	one and a half years
abdominal distension	As measure by patient reported outcome measures	one and a half years
mucous stool	As measure by patient reported outcome measures	one and a half years
life quality parameters	As measure by healthy survey, SF-36	one and a half years

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Chair: Junkang Liu, Doctor, Third MMU

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: diarrhea; abdominal pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: liujunkang; dongying (Other Grant/Funding Number: Dongying leader pharmaceutical co.,LTD)