UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005362 |
|---|---|
| Receipt number | R000006363 |
| Scientific Title | Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2013/04/01 09:19:38 |
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Basic information
Public title
Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
Acronym
Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.
Scientific Title
Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
Scientific Title:Acronym
Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.
Region
| Japan |
Condition
Condition
Patients with rheumatoid arthritis with anemia taking NSAIDs
Classification by specialty
| Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of mesalazine for the treatment of intestinal injury caused by NSAIDs
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic findings by capsule endoscopy.
Side effects due to the mesalazine treatment.
Key secondary outcomes
Patients' joint and abdominal symptoms. Serum cytokines. Fecal calprotectin
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 |
Interventions/Control_1
Treatment with mesalazine
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Rheumatoid arthritis patients aged older than 20y and younger than 70 y who were taking NSAIDs for more than 3 mo and will take NSAIDs for the additional 8 w.
2)The patients with anemia (Hg levels lower than 13.8 g/dl (men) 12.0 g/dl(women) and without abnormalities in the liver and renal function tests.
Key exclusion criteria
Patients treated with mesalazine or salicylic acid 2 weeks proior to the entry of this study.
Patients with escalating the dose of anti-rheumatoid arthritis drugs such as aspirins or proton pump inhitors.
Patients took gastroprotective agents such as rebamipide, ecabet sodium, misoprostol.
Patients being treated with high-dose corticosteroids (more than 15 mg/day of prednisolone.
Patients treated with biologics 90 days prior to the entry of this study.
Patients who were allergic to or suffered from side effects by mesalazine of salicylic acids.
Patients incapable of swallowing capsule endoscopy.
Patients suspicious of intestinal strictures.
Patients with malignancies.
Pregnancy or possible pregnancy.
Patients with side effects by other previous clinical studies.
Patients who were considered unsuitable for this study by doctors.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicin
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
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
| 2011 | Year | 04 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 01 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006363
