treatment of NSAID induced small bowel enteropathy
Conditions
Interventions
Trade Name: Salofalk 1000 mg Granu-Stix®
Pharmaceutical Form: Gastro-resistant capsule*
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Concentration unit: g gram(s)
Concentration type: equal
Concen
Sponsors
Prof. Dr. Istvan Racz
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the mucosal changes (measured as number, type and localisation of small bowel mucosal lesions detected by VCE) after 4 weeks treatment with 3 g mesalazine granules ;Secondary Objective: to assess the changes of dyspeptic symptoms and laboratory parameters. ;Primary end point(s): Rate of mucosal healing measured by seven-point score system evaluated by VCE | — |
Countries
Hungary
Outcome results
None listed