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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001538
Receipt No. R000001728
Scientific Title Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Date of disclosure of the study information 2008/12/01
Last modified on 2012/12/01

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Basic information
Public title Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Acronym Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Scientific Title Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Scientific Title:Acronym Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Region
Japan

Condition
Condition NSAIDs-induced small bowel injury
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the healing effect of Polaprezinc for NSAIDs-induced small bowel injury by using video capsule endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Capsule endoscopic findings (number of ulcers/erosions and red spots)
Key secondary outcomes Laboratory data and subjective symptom

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Polaprezinc
Interventions/Control_2 placebo
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 The patients who have taken NSAIDs for more than one month and who will take NSAIDs for one month after enrollment.
Key exclusion criteria 1) The patients with dysphagia.
2) Pregnant or lactating women.
3) The patients who have history of the ileus or stricture or fistula of the intestine.
4) The patients who have Crohn's disease, Behchet's disease.
5) The patient with pacemaker or other medical electronic equipment.
6) The patient who have taken mucoprotective agent or took it within one month before enrollment.
7) The patient who have severe anemia (less than Hb 8.0mg/dl) or a hematemesis or a melena.
8) The patients who have taken antibiotics or took it within one month before enrollment.
9) The patients who have severe hiatal hernia.
10) The patient who take COX-2 inhibitor (celecoxib) only or low-dose aspirin only.
11) The patients who have severe illness.
12) The patients who have history of abdominal operation or radiation therapy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hosenao@db3.so-net.ne.jp

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department

Funding Source
Organization Division of Gastroenterology,Department of Internal Medicine, Keio University and OLYMPUS medical systems corp. and ZERIA pharmaceutical CO.,Ltd.
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 12 Month 01 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 Terminated
Date of protocol fixation
2008 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 01 Day
Last modified on
2012 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001728

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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