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

T

Third Military Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Drug: placebo
Drug: N-acetyl-D-glucosamine

Study type

Interventional

Funder types

Other

Identifiers

NCT01893606
liujunkang
dongying (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

180 participants in 2 patient groups, including a placebo group

Starch capsule
Placebo Comparator group
Description:
During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper.
Treatment:
Drug: placebo
N-acetyl-D-glucosamine
Experimental group
Description:
During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken.
Treatment:
Drug: N-acetyl-D-glucosamine

Trial contacts and locations

1

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Central trial contact

Yanxia Liu, Master; Junkang Liu, Doctor

Data sourced from clinicaltrials.gov

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