Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-03 @ 9:15 AM
Study NCT ID:
NCT02504060
Status:
UNKNOWN
Last Update Posted:
2015-07-21
First Post:
2015-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000117', 'term': 'Acetylglucosamine'}], 'ancestors': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Pain Intensity', 'timeFrame': 'one and a half years', 'description': 'As measured by numerical rating scale'}, {'measure': 'Stool Consistency', 'timeFrame': 'one and a half years', 'description': "As measured by Bristol ' s scale"}], 'secondaryOutcomes': [{'measure': 'General symptoms feel grading', 'timeFrame': 'one and a half years', 'description': 'As measure by patient reported outcome measures'}, {'measure': 'defecation frequency', 'timeFrame': 'one and a half years', 'description': 'As measure by patient reported outcome measures'}, {'measure': 'abdominal distension', 'timeFrame': 'one and a half years', 'description': 'As measure by patient reported outcome measures'}, {'measure': 'Defecation urgency', 'timeFrame': 'one and a half years', 'description': 'As measure by patient reported outcome measures'}, {'measure': 'life quality parameters', 'timeFrame': 'one and a half years', 'description': 'As measure by healthy survey, SF-36'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diarrhea', 'abdominal pain'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is a randomized double-blind placebo-controlled clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment group, 360 for placebo group) in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS(numerical rating scale) 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 (12 weeks), follow-up period (2 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, defecation urgency and quality of life parameters (IBS-QOL scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily signed the informed consent form.\n* Man or woman, aged 18 to 65 years, inclusive.\n* Based on the Roman III diagnostic criteria for diagnosis of IBS-D subjects, recurrent abdominal pain accompanied with abdominal discomfort or not, monthly attack within the past 3months at least 3 days. With two or more of the following three kinds of symptoms:\n\nAt least a portion of the time abdominal pain or defecate increase when discomfort.\n\nAt least a portion of the time abdominal pain or the row of loose stools when discomfort.\n\nAt least a portion of the time abdominal pain or discomfort improved after defecation.\n\nSymptoms for at least 6 months before diagnosis.\n\n* 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 per week.\n* During the screening period，patients should answer the questions of electronic log completely following the requirements for 10days or more.\n* Patients are willing to stop drugs for abdominal symptoms or diarrhea which are in violation of the scheme, and take medicine prescribed in the scheme.\n* Patients agree to not change the lifestyle significantly that may affect the symptoms of IBS-D from signing up the Informed Consent Form to the last experiment.\n* The illness recured after a normal colonoscopy report within one year that was provided by this hospital or a grade first class teaching hospital, include polyp of colon (less than 3mm,the number of less than 5) patients who taked therapeutic endoscopy and recurrenced within one year; or those that get a normal colonoscopy report in this hospital or a grade first class teaching hospital before screening but have a history of bowel preparation, should be chosen when next attack.\n\nExclusion Criteria:\n\n* History of organic gastrointestinal diseases: Chronic pancreatitis (cp), inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, gastrointestinal tumor, or other organic diseases etc.\n* History of abdominal and pelvic surgery ( not including appendectomy and intestinal polyposis (\\<3mm) after treatment within one year ).\n* The non-intestinal disease of digestive system such as Peptic ulcer, tuberculous peritonitis, cirrhosis etc.\n* Heart, lung, kidney and other important organs have severe lesions, immune regulatory disease, metabolic disease (diabetes, thyroid disease) or malignant tumor, reproductive system diseases such as ovarian cysts, endometriosis, etc.\n* Laboratory tests or Electrocardiogram were significantly abnormal, and judging by the researchers may damage the patient safety or successful completion of the clinical research:\n\nMale hemoglobin \\<120g/L, female hemoglobin \\<100g/L;\n\nMale serum creatinine≥133umol/L, female serum creatinine≥124umol/L; or creatinine clearance rate≤60ml/min;\n\nChronic liver disease and/or abnormal liver function, defined as AST (aspartate aminotransferase) \\> 1.5 x ULN (Upper Limit Of Normal) and/or ALT (alanine aminotransferase) \\> 1.5 x ULN and/or total bilirubin \\> 1.5x ULN;\n\n* Serious psychiatric patients( Hamilton Depression Scale scores\\>20).\n* History of drug abuse or alcohol abuse.\n* Allergic to this study drug.\n* Concomitant medication is unable to stop or use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology, parasympathetic inhibitors, muscle relaxants, antidiarrheal, opiates, etc.\n* Do not fill in the electronic log of one week before entering the group (-1 week) completely.\n* Pregnant or lactating women\n* Is participating in clinical trials or have finished it less than 3 months.\n* Other researchers think not suitable for the list.'}, 'identificationModule': {'nctId': 'NCT02504060', 'briefTitle': 'Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Multicenter Randomized Double-blind Placebo-controlled Clinical Trials to Evaluate the Clinical Efficacy and Safety of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment', 'orgStudyIdInfo': {'id': 'TMMUBC'}, 'secondaryIdInfos': [{'id': 'dongying', 'type': 'OTHER_GRANT', 'domain': 'Dongying leader pharmaceutical co.,LTD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Starch capsule', 'description': 'During the 12- weeks treatment phase of the study, the daily dose of 3 tablets will be taken 30 minutes after breakfast, lunch and supper.', 'interventionNames': ['Drug: Starch Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'N-acetyl-D-glucosamine', 'description': 'During the 12- weeks treatment phase of the study, the daily dose of 100mg\\*3 (3 tablets) will be taken 30 minutes after breakfast, lunch and supper.', 'interventionNames': ['Drug: N-acetyl-D-glucosamine']}], 'interventions': [{'name': 'Starch Placebo', 'type': 'DRUG', 'armGroupLabels': ['Starch capsule']}, {'name': 'N-acetyl-D-glucosamine', 'type': 'DRUG', 'otherNames': ['Atysamine(ATSM)'], 'armGroupLabels': ['N-acetyl-D-glucosamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Hou, Doctor', 'role': 'CONTACT', 'email': 'yejin8688@sina.com', 'phone': '13035143646'}], 'facility': 'Union Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Junkang Liu, Doctor', 'role': 'CONTACT', 'email': 'liujunkang@163.com', 'phone': '+86-023-68752191'}, {'name': 'Yanxia Liu, Master', 'role': 'CONTACT', 'email': 'liuyibin_04@163.com', 'phone': '+86-023-68752372'}], 'overallOfficials': [{'name': 'Junkang Liu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Third MMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The director of microecological pharmaceutical research', 'investigatorFullName': 'Liujunkang', 'investigatorAffiliation': 'Third Military Medical University'}}}}