intestinal inflammation
Conditions
Interventions
Product Name: Omeprazol
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OMEPRAZOLE
Other descriptive name: OMEPRAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Linköping university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age 18 – 64 years • healthy individuals (individuals who are not known to suffer of any significant illness relevant to this study and should be within the ordinary range of body measurements, such as weight, and whose mental state is such that they are able to understand and give valid consent to the study; they should not have any disease or condition requiring regular medication) • written informed consent signed • normal faecal calprotectin test, blood count and Helicobacter pylori test • regular bowel movements 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • PPI, NSAID or ASA (acetyl salicylic acid) intake in the past month • history of regular PPI, NSAID or ASA use • intolerance to PPIs or NSAIDs • history of gastrointestinal diseases or bleeding • conditions associated with bleeding disorders • asthma, cirrhosis, hepatic porphyria, liver failure, kidney failure, heart failure, ischemic heart disease, peripheral arterial disease and cerebrovascular disease • pregnancy or lactating • current alcohol misuse • participation in another clinical trial involving medicinal products within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate how omeprazole intake affects faecal calprotectin levels with and without concurrent coadministration of oral diclofenac and to assess how long it takes for an increased faecal calprotectin to return to normal levels after omeprazole intake with and without concurrent coadministration of oral diclofenac. ;Secondary Objective: Not applicable;Primary end point(s): Change in FC level during and after drug administration compared to baseline;Timepoint(s) of evaluation of this end point: Day 0 (the day before start of drug administration), 2, 4, 7, 10 and 14 during drug administration and day 17, 21, 28 and 35 after discontinuation of the drug (± 2 days), then at 7-day intervals (± 2 days) until normalisation of FC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of participants with level of FC over upper limit of normal reference value;Timepoint(s) of evaluation of this end point: Day 0, 2, 4, 7, 10 and 14 during drug administration and day 17, 21, 28 and 35 after discontinuation of the drug (± 2 days), then at 7-day intervals (± 2 days) until normalisation of FC. | — |
Countries
Sweden
Contacts
Public ContactLinköping University Hospital
Department of Clinical and Experimental Medicine, Department of Gastroenterology, Linköping University
Outcome results
None listed