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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
N-acetyl-D-glucosamine
placebo
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring diarrhea, abdominal pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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;

Sites / Locations

  • Daping hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Starch capsule

N-acetyl-D-glucosamine

Arm Description

During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper.

During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken.

Outcomes

Primary Outcome Measures

Abdominal Pain Intensity
As measured by numerical rating scale
Stool Consistency
As measured by Bristol ' s scale

Secondary Outcome Measures

General symptoms feel grading
As measure by patient reported outcome measures
defecation frequency
As measure by patient reported outcome measures
abdominal distension
As measure by patient reported outcome measures
mucous stool
As measure by patient reported outcome measures
life quality parameters
As measure by healthy survey, SF-36

Full Information

First Posted
June 6, 2013
Last Updated
July 23, 2015
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01893606
Brief Title
Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Official Title
Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
diarrhea, abdominal pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Starch capsule
Arm Type
Placebo Comparator
Arm Description
During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper.
Arm Title
N-acetyl-D-glucosamine
Arm Type
Experimental
Arm Description
During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken.
Intervention Type
Drug
Intervention Name(s)
N-acetyl-D-glucosamine
Other Intervention Name(s)
Atysamine (ATSM)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Abdominal Pain Intensity
Description
As measured by numerical rating scale
Time Frame
one and a half years
Title
Stool Consistency
Description
As measured by Bristol ' s scale
Time Frame
one and a half years
Secondary Outcome Measure Information:
Title
General symptoms feel grading
Description
As measure by patient reported outcome measures
Time Frame
one and a half years
Title
defecation frequency
Description
As measure by patient reported outcome measures
Time Frame
one and a half years
Title
abdominal distension
Description
As measure by patient reported outcome measures
Time Frame
one and a half years
Title
mucous stool
Description
As measure by patient reported outcome measures
Time Frame
one and a half years
Title
life quality parameters
Description
As measure by healthy survey, SF-36
Time Frame
one and a half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junkang Liu, Doctor
Phone
+86-023-68752191
Email
liujunkang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanxia Liu, Master
Phone
+86-023-68752190
Email
liuyibin_04@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junkang Liu, Doctor
Organizational Affiliation
Third MMU
Official's Role
Study Chair
Facility Information:
Facility Name
Daping hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongfeng Chen, doctor
Phone
13883032812

12. IPD Sharing Statement

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

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