UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001377
Receipt number 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 22:56:18

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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 or person

Institute

Nagoya University Graduate School of Medicine Department of Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.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