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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001377
Receipt No. R000001671
Scientific Title Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope
Date of disclosure of the study information 2008/09/17
Last modified on 2011/02/10

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Basic information
Public title Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope
Acronym The change of symptom of irritable bowel syndrome is correlative with the capsule transit time.
Scientific Title Examination of large intestine contraction patterns by mosapride citrate for irritable bowel syndrome (IBS, constipation type) using a capsule endoscope
Scientific Title:Acronym The change of symptom of irritable bowel syndrome is correlative with the capsule transit time.
Region
Japan

Condition
Condition Irritable bowel syndrome (constipation type)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Video capsule endoscopy (VCE) is a minimally invasive diagnostic test for organic disorders of the small intestine, which enables observation of the movements of all of the small intestine and part of the large intestine under physiological conditions. However, there are no reports of quantification of the image data to examine intestinal contraction patterns. We have planned clinical research to examine the effects of mosapride citrate on IBS (constipation type) using VCE image data and quantified data. In this study, the problem of VCE retention in the stomach could be mitigated by administration of mosapride citrate, which could further increase the usefulness of VCE, which will probably be widely used in the future.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Symptoms of IBS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Mosapride citrate 15 mg taken once daily in the morning after meal. Administration period is 4 to 5 weeks. Capsule endoscopy conducted before administration and after end of administration period.
Interventions/Control_2
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients with irritable bowel syndrome (IBS, constipation type) in whom the lack of recognizable organic disorders has been confirmed by colonoscopy (CF), and whose blood AST (GOT) and ALT (GPT) are no more than 2 times the upper limit of the facility standard (based on Rome III criteria).
Key exclusion criteria 1) Patients who have taken mosapride citrate or other gastrointestinal function improving drug within 1 week before enrollment in prior treatment.
2) Patients with serious hepatic or renal impairment.
3) Patients taking a gastrointestinal function improving drug other than mosapride citrate concomitantly.
4) Patients with previous gastrointestinal surgery.
5) Patients with long-term use of nonsteroidal antiphlogistic analgetics.
6) Patients undergoing radiation therapy.
7) Patients taking calcium antagonists.
8) Patients taking iron or sucralfate preparations who cannot stop before start of the study.
9) Patients with ulcers, hemorrhage, gastrointestinal stenosis, obstruction, etc.
10) Patients with Crohn's disease.
11) Patients with an embedded electronic medical device such as a cardiac pacemaker.
12) Patients with dysphagia.
13) Patients with serious gastrointestinal diverticular disease.
14) Patients complicated by diabetes.
15) Patients with a history of allergy to mosapride citrate.
16) Patients whom the attending physician judges to be an inappropriate subject.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Goto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nakamura Masanao
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65 Tsurumai-Cho, Showa-Ku, Nagoya-Shi, Aichi-Ken
TEL 052-744-2172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine Department of Gastroenterology
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2008 Year 09 Month 17 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 Completed
Date of protocol fixation
2008 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 09 Month 17 Day
Last modified on
2011 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001671

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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