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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014