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

Last updated: July 23, 2015
Sponsor: Third Military Medical University
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT01893606
liujunkang
dongying
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Man or woman, aged 18 to 65 years, inclusive.

  • Based on the Roman III diagnostic criteria for diagnosis of IBS-D subjects, recurrentabdominal pain or discomfort (hard to describe the discomfort of pain), monthly attackwithin the past 3months at least 3 days. With two or more of the following three kindsof 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 plusand the days which at least more than one time a stool type are 6 or 7 type over 2days/week.

  • Voluntarily signed the informed consent form

Exclusion

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 otherserious diseases and psychiatric patients, AST(aspartate aminotransferase), ALT (alanine aminotransferase)> 1.5 times, BUN (blood urea nitrogen)> 1.2 times, Cr > 1.0times normal.

  • The disease of lactose intolerance, gallstones, endometriosis, easily confused withIBS symptoms of ;

  • Progressive weight loss;

  • Concomitant medication is unable to stop but affect the gastrointestinal movement andfunction in the experiment, such as antibiotic drugs, the drugs of regulating theintestinal microecology;

  • Concomitant medication use continuously for more than a week but affect thegastrointestinal movement and function in the experiment, such as parasympatheticinhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc;

  • Other researchers think not suitable for the list;

Study Design

Total Participants: 180
Study Start date:
April 01, 2013
Estimated Completion Date:
July 31, 2017

Connect with a study center

  • Daping hospital

    Chongqing, Chongqing 400038
    China

    Active - Recruiting

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