EnteropathyNCT00854490
Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users
An observational study of Enteropathy, run by Nagoya University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Enteropathy
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic NSAID users
Who may be able to join
- written informed consent
- 20 to 85 years of age
- RA, OA, or low back pain
- taking oral diclofenac sodium over 3 months
- No change of drugs before 3 months
- under 5 mg of corticosteroid use
- CRP < 1mg/dl
Who cannot join
- known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
- prostaglandins, metronidazole or salazosulfapyridine
- can not swallow
- with pacemaker
- after gastrointestinal operation
- serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
- any other conditions that the investigator feels would interfere with data interpretation or create under risk
Trial locations and contacts
1 site in 1 country.
Japan1 site
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550
Naoki Ohmiya, M.D., Ph.D>, 81-52-744-2172, nohmiya@med.nagoya-u.ac.jp
About this study
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.
- Conditions
- Enteropathy
- Medical subject headings
- Intestinal Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnteropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854490
- Sponsor's protocol ID
- NO-002
- Status last verified
- Sep 2009
- First submitted
- 2 Mar 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users
- ClinicalTrials.gov ID
- NCT00854490
- Acronym / sponsor ID
- NO-002
- Conditions
- Enteropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Oct 2009
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic NSAID users
Key inclusion criteria (7 listed)
- written informed consent
- 20 to 85 years of age
- RA, OA, or low back pain
- taking oral diclofenac sodium over 3 months
- No change of drugs before 3 months
Key exclusion criteria (7 listed)
- known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
- prostaglandins, metronidazole or salazosulfapyridine
- can not swallow
- with pacemaker
- after gastrointestinal operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteropathy, run by Nagoya University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naoki Ohmiya, MD., Ph.D. (81-52-744-2172, nohmiya@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.