Open label, uncontrolled pilot study on the effect of mucosal healing with 3 g mesalazine granules in NSAID induced small bowel enteropathy, evaluated by video capsule endoscopy after 4 weeks of treatment.An investigator initiated phase II pilot study.

• Conditions: treatment of NSAID induced small bowel enteropathy

• Registration Number: EUCTR2007-001317-42-HU
• Lead Sponsor: Prof. Dr. Istvan Racz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Signed informed consent,
• Man or woman between 18 and 75 years of age,
• At least one month history of daily naproxen use of 1000 mg for osteoarthritis,
rheumatoid arthritis, or nonspecific arthritis, to avoid gastroduodenal mucosal
injury the patients have to be treated with standard dose of proton pump
inhibitor
• Patients with performed complete VCE <7 days prior to inclusion and diagnosed
small bowel NSAID enteropathy (minimum > 4 enteropathy score),
• No strictures on previous examinations, as previously proven by barium small
bowel follow through, enteroclysis and/or patency test capsule,
• Women of child-bearing potential, if heterosexually active, have to apply a highly
effective method of birth control, which is defined as those which result in a low
failure rate when used consistently and correctly such as implants, injectables,
combined oral contraceptive method, some intrauterine devices (IUDs), sexual
abstinence, or vasectomised partner. The investigator is responsible for
determining whether the subject has adequate birth control for study
participation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with evidence of inflammatory small bowel disease (e.g., Crohn’s
disesase),
•Patients with pacemaker,
•Patients who cannot undergo study procedures due to swallowing disorders,
•Planned or actual pregnancy or lactation,
•Patients receiving treatment of sulphasalazine, mesalazine, 4-ASA, metronidazole,
or misoprostol at least for 12 weeks prior to baseline capsule endoscopy,
•Use of other NSAIDs than naproxen and aspirin within 30 days prior the
enrolment in this study,
•Intake of corticosteroids (oral and/or rectal routes) within 30 days prior to
enrolment in the study,
•Patient receiving any immunosuppressive (azathioprine, 6-MP, etc.) agents during
30 days prior the study enrolment,
•Patient with any other disease or condition which may interfere with study
assessments as judged by the investigator,
•Alcoholism or drug addiction,
•Patients with severe renal or hepatic impairment,
•Patients who are allergic to salicylate or 5-ASA derivates or to naproxen,
•Patients who are unlikely to comply with the protocol,
•Known previous or concurrent malignancy (other than that considered surgically
cured, with no evidence for recurrence for 5 years),
•Participation in another clinical trial within the last 30 days, simultaneous
participation in another clinical trial, or previous participation in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified