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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038354
Receipt No. R000043709
Scientific Title Clinical research of Lagnos NF oral jelly 12 g for chronic constipation patients with diabetes, with diabetes and chronic kidney disease, or without diabetes
Date of disclosure of the study information 2019/10/21
Last modified on 2020/05/14

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Basic information
Public title Clinical research of Lagnos NF oral jelly 12 g for chronic constipation patients with diabetes, with diabetes and chronic kidney disease, or without diabetes
Acronym Clinical research of Lagnos NF oral jelly 12 g for chronic constipation patients with diabetes, with diabetes and chronic kidney disease, or without diabetes
Scientific Title Clinical research of Lagnos NF oral jelly 12 g for chronic constipation patients with diabetes, with diabetes and chronic kidney disease, or without diabetes
Scientific Title:Acronym Clinical research of Lagnos NF oral jelly 12 g for chronic constipation patients with diabetes, with diabetes and chronic kidney disease, or without diabetes
Region
Japan

Condition
Condition Chronic constipation with diabetes mellitus or without diabetes mellitus
Classification by specialty
Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Japanese patients with chronic constipation who are diabetic or non-diabetic patients are treated with Lagnos NF jelly twice a day for 8 weeks with dose adjustment depending on the patient's condition for constipation. Efficacy will be evaluated before and after administration, and comparisons will be made between study groups.
Basic objectives2 Others
Basic objectives -Others The effects on intestinal microbiota, the effects on serum creatinine and BUN, and the effects on uremic toxicin indoxyl sulfate etc. are similarly evaluated.
As for diabetic patients, there are many patients with chronic kidney disease. So we also compare the above items between CKD and non-CKD patients with chronic constipation and diabetic mellitus.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline SBM frequency at week 8
Key secondary outcomes (1)Weekly average of SBM frequency at week 8
(2)Weekly average of SBM frequency at week 0, 4 and change from baseline SBM requency at week 4
(3)Weekly average of the following test items at week 0, 4, 8 and change from baseline at week 4 and 8. Complete SBM frequency, defecation frequency, straning, sensetion of incomplete evacuation, stool consistency score, abdominal distension score, abdominal discomfort
(4)Use of rescue medication and cumulative use over 8 weeks
(5)The following test items at 0, 4, 8 week-visit and change from baseline at week 4 and 8 Severity of constipation, satisfaction score, QOL score (JPAC-QOL, GSRS)"
(6)Glucose, HbA1c, creatinine, BUN, indoxyl sulfate, TMAO, eGFR at week 0, 8 and changes from baseline at week 8
(7)The following test items at 0 and 8 weeks
Fecal bacterial flora, short-chain fecal fatty acid, putrefactive products and fecal bile acids"
(8)Adverse events, side effects

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Luganos NF jelly is orally administered twice a day for 8 weeks to chronic constipation patients with diabetes.
Interventions/Control_2 Luganos NF jelly is orally administered twice a day for 8 weeks to chronic constipation patients without diabetes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who have chronic constipation and who need to take constipation medications (including IBS-C) for daily clinical use
(2) Patients who have not changed the type of constipation treatment, medication or dosage for 4 weeks before the start of medication, or who have not been treated with constipation treatment
(3)Japanese patients who were 20 years or older at the time of giving consent, and who signed informed consent documents.
(4)Patients who can make outpatients visit and are not scheduled to be hospitalized
"(5)Patients who can keep bowel movement diary and answer questionnaires on their own
(6)Patients with stable medical condition who are expected to have no change in medication content, except for the treatment for constipation during the study period

Key exclusion criteria 1:Patients who have been taking lactulose for 4 weeks before the start of medication
2:Patients who have newly taken concomitant medications (anticholinergic or cholinergic drug, opioid, antispasmodic drug, gastrointestinal tract prokinetic drug, GLP-1 receptor agonist, Metformin preparations, a-glucosidase inhibitors) that may affect their bowel habits for 4 weeks before or just before the start of medication.
3:Patients with constipation due to organic disease, patients with large colon or large rectum
4:Patient with pseudo intestinal obstruction
5:Patients who underwent abdominal surgery within one year before the screening test started
6:Patients who have had digestive tract resection (except for polypectomy)
7:Patients with cancer (except cured patients), patients with severe liver disease, severe heart disease
8:Patients who have suffered a stroke within 26 weeks before the screening test starts
9:Patients with galactosemia
10:Patients who participated in other clinical trials within 12 weeks before the screening test starts
11:Patients who donated blood within 12 weeks before the screening test starts
12:Patients who are or may be pregnant, who wish to become pregnant, or who are lactating
13:Patients who were judged by the doctor in charge to be inappropriate for the participation in this clinical study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name kunio
Middle name
Last name kasugai
Organization Aichi medical University of medicine
Division name gastroenterology
Zip code 480-1195
Address 1-1 karimata yazako nagakute city aichi
TEL 0561-62-3311
Email kasugai.kunio.527@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name kazunori
Middle name
Last name adachi
Organization Aichi medical University of medicine
Division name gastroenterology
Zip code 480-1195
Address 1-1karimata yazako nagakute city aichi
TEL 0561-62-3311
Homepage URL
Email k.adachi@aichi-med-u.ac.jp

Sponsor
Institute Aichi medical University of medicine
Institute
Department

Funding Source
Organization Self-funding



Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi medical University of medicine
Address 1-1karimata yazako nagakute city aichi
Tel 0561-62-3311
Email k.adachi@aichi-med-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 07 Month 22 Day
Date of IRB
2019 Year 07 Month 22 Day
Anticipated trial start date
2019 Year 10 Month 18 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 21 Day
Last modified on
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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