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

This study is currently recruiting participants.
Verified July 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Liujunkang, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01893606
First received: June 6, 2013
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: N-acetyl-D-glucosamine
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
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
Official Title: Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Abdominal Pain Intensity [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measured by numerical rating scale

  • Stool Consistency [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measured by Bristol ' s scale


Secondary Outcome Measures:
  • General symptoms feel grading [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measure by patient reported outcome measures

  • defecation frequency [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measure by patient reported outcome measures

  • abdominal distension [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measure by patient reported outcome measures

  • mucous stool [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measure by patient reported outcome measures

  • life quality parameters [ Time Frame: one and a half years ] [ Designated as safety issue: Yes ]
    As measure by healthy survey, SF-36


Estimated Enrollment: 180
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Starch capsule
During the two weeks screening phase of the study, the daily dose of 3 tablet 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 Name: Atysamine (ATSM)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893606

Contacts
Contact: Junkang Liu, Doctor +86-023-68752191 liujunkang@163.com
Contact: Yanxia Liu, Master +86-023-68752190 liu_yinbin@163.com

Locations
China, Chongqing
Daping hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Dongfeng Chen, doctor    13883032812      
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Chair: Junkang Liu, Doctor Third MMU
  More Information

No publications provided

Responsible Party: Liujunkang, The director of microecological pharmaceutical research, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01893606     History of Changes
Other Study ID Numbers: liujunkang, dongying
Study First Received: June 6, 2013
Last Updated: July 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Third Military Medical University:
diarrhea
abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014