UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002498
Receipt number R000003062
Scientific Title Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy
Date of disclosure of the study information 2009/09/15
Last modified on 2010/05/25 15:55:46

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Basic information

Public title

Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy

Acronym

Investigation of mucosal protective agents for small intestinal mucosal injury.

Scientific Title

Investigation of incidence of loxoprofen-induced small-intestinal mucosal injury and inhibitory effect of irsogladine maleate on its induction using capsule endoscopy

Scientific Title:Acronym

Investigation of mucosal protective agents for small intestinal mucosal injury.

Region

Japan


Condition

Condition

NSAID-induced small-intestinal mucosal injury

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the rate of the incidence of small intestinal mucosal injury induced by loxoprofen and to investigate the inhibitory effect of irsogladine maleate on its induction using capsule endoscopy

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of the incidence of small intestinal mucosal injury evaluated with capsule endoscopy.

Key secondary outcomes

1. Anemia (Evaluated by blood test results before and after the administration of the medicines)
2. Small bowel transit time of capsule endoscopy.
3. Subjective symptoms
4. Confirmation of adverse events


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1.Loxoprofen, Omeprazole and irsogladine maleate
2.washout period
3.Loxoprofen, Omeprazole and placebo

Interventions/Control_2

1.Loxoprofen, Omeprazole and placebo
2.washout period
3.Loxoprofen, Omeprazole and irsogladine maleate

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

H. Pylori negative volunteers aged 20 years or older, who understand the meaning and purpose of this clinical study and have consented to participate in it. They need to have a history of pain-causing conditions such as lumbago, frozen shoulder, Cervico-omo-brachial syndrome, arthalgia, myalgia, toothache, trauma, acute upper respiratory tract infection, headache and neuralgia and are considering NSAIDs use in future

Key exclusion criteria

1) People with dysphagia.
2) People with organ dysfunction such as kidney disease, liver disease and heart disease.
3) Pregnant or possibility of pregnancy.
4) People with a history of allergic reactions to NSAIDs(nonsteroidal antiinflammatory drug) or other drugs. People with allergies.
5) People with history of asthma.
6) People with history of gastrointestinal surgeries, or who are suspicious of having a stenosis of the gastrointestinal tract.
7) People with a history of gastrointestinal hemorrhage or ulcer diseases.
8) People who are diagnosed with ulcers, apparent hemorrhagic lesions or tumors in the lower gastrointestinal tract by capsule endoscopy.
9) People with positive results of H. Pylori test.
10) People with a history of H.pylori eradication therapy.
11) People who are taking any kinds of medicines or took them within one month. Use of NSAIDs and mucosal protectant should be carefully excluded in particular.
12) People who are judged not suitable for the study by the investigator in charge or other investigators.

Target sample size

19


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironori Yamamoto

Organization

Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University

Division name

Department of Endoscopic Research and International Education (Funded by Fujifilm)

Zip code


Address

3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498

TEL

0285-58-7539

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoyuki Nishimura

Organization

Department of Medicine, Division of Gastroenterology, Endoscopy Center, Jichi Medical University

Division name

Department of Medicine, Division of Gastroenterology

Zip code


Address

3311-1 Yakushiji Shimotsuke-shi, Tochigi-ken 329-0498

TEL

0285-58-7539

Homepage URL


Email

naoyukin@jichi.ac.jp


Sponsor or person

Institute

Department of Endoscopic Research and International Education (Funded by Fujifilm)
in Jichi Medical University

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

2009 Year 09 Month 15 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

2009 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2011 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 09 Month 15 Day

Last modified on

2010 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003062


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name