E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
treatment of NSAID induced small bowel enteropathy |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
to assess the changes of dyspeptic symptoms and laboratory parameters.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of mucosal healing measured by seven-point score system evaluated by VCE |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |