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

NCT01893606 | Unknown Phase 2 DMC

• 2 other identifiers: liujunkangdongying
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome

Keywords

diarrhea; abdominal pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• General symptoms feel grading

  one and a half years

• defecation frequency

  one and a half years

• abdominal distension

  one and a half years

• mucous stool

  one and a half years

• life quality parameters

  one and a half years

Study Arms (2)

Starch capsule

PLACEBO COMPARATOR

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

N-acetyl-D-glucosamine

EXPERIMENTAL

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

Interventions

N-acetyl-D-glucosamine DRUG

Also known as: Atysamine (ATSM)

N-acetyl-D-glucosamine

placebo DRUG

Starch capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea; Abdominal Pain

Interventions

Acetylglucosamine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Glucosamine; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Junkang Liu, Doctor

  Third MMU

  STUDY CHAIR

Central Study Contacts

Junkang Liu, Doctor

CONTACT

+86-023-68752191; liujunkang@163.com

Yanxia Liu, Master

CONTACT

+86-023-68752190; liuyibin_04@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of microecological pharmaceutical research

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

CN (1)