Healthy volunteers.
Conditions
Interventions
Trade Name: Prexige 100mg film-coated tablets
Product Name: Prexige
Product Code: COX189
Pharmaceutical Form: Film-coated tablet
INN or
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Healthy male or female subjects = 18 years of age 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; female subjects of child-bearing potential must use a reliable method of contraception throughout the study 2. Subjects with known hypersensitivity to any of the study drugs 3. Subjects who have experienced, any time in the past, asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reaction after taking acetylsalicylic acid (ASA)/ aspirin or NSAIDs 4. Subjects with evidence of cardiovascular disorder: congestive heart failure (NYHA class II–IV), established ischemic heart disease, peripheral arterial disease or cerebrovascular disease; cardiac dysfunction, cardiac failure or left ventricular dysfunction 5. Subjects with evidence of hepatic or gastrointestinal disorder: severe hepatic disease (Child-Pugh >9), history of alcohol abuse; disease of gall bladder and pancreas; active peptic ulceration within the previous 12 months, gastrointestinal bleeding within the last 5 years (except history of minor lower gastro-intestinal tract bleeding, such as from hemorrhoids or anal fissures) or history of gastro-esophageal reflux disease or hiatus hernia; inflammatory bowel disease. 6. Subjects with evidence of renal disorder: (estimated creatinine clearance <30 ml/min) or subjects with impaired renal function, pre-existing edema or severely dehydrated subjects 7. Subjects with hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome 8. Use of other investigational drugs at the time of enrollment, or within 30 days or 10 half-lives prior to screening, whichever is longer. 9. Regular use and any use within two weeks before visit 1 of aspirin (even low dose) or other NSAIDs or other medications with suspected ulcerogenic potential. 10. Any active gastrointestinal disease or history of abdominal surgery or radiation, any other symptoms of luminal narrowing or risk factors for delayed transit; known or suspected complete or partial stenosis of the small intestine or swallowing disorders; prior gastric or intestinal surgery or history of delayed gastric emptying or diabetic gastroparesis. 11. Use of anti-ulcer medications (sucralfate, antacids, H2 receptor antagonists, PPIs and misoprostol). 12. Hemoglobin less than 10 g/dl (women) or 12 g/dl (men) at screening. 13. Visit 2 positive fecal occult blood test results. 14. Visit 2 VCE showing any lesion. 15. Need for regular use of medication, other than oral contraceptives and hormone replacement therapy. 16. Current smokers and subjects who smoked within one month prior to visit 1 day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate, by video capsule endoscopy (VCE), that the percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) is significantly lower for lumiracoxib than for naproxen + omeprazole.; Secondary Objective: The secondary objectives of this study are to investigate further the favorable small bowel safety and tolerability profile of lumiracoxib as compared to naproxen + omeprazole by testing the hypotheses that: • the total number of small bowel mucosal breaks (with or without hemorrhage) detected by VCE for lumiracoxib is significantly lower than that for naproxen + omeprazole; • the percentage of subjects with one or more small bowel lesion detected by VCE is significantly lower for lumiracoxib than for naproxen + omeprazole. • the total number of small bowel lesions for lumiracoxib is significantly lower than that for naproxen + omeprazole; • the value of small bowel inflammation (as measured by calprotectin test) for lumiracoxib is significantly lower than that for naproxen + omeprazole; • the value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars) is significantly lower than that for naproxen + omeprazole. ; Primary end point(s): The primary objective of this study is to demonstrate that study medication with lumiracoxib 100 mg od (LUM) results in a smaller proportion of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) than does naproxen + omeprazole (NAP+OME). The odds of occurrence of small bowel mucosal breaks in the two study medication groups will be compared. The null hypothesis of no difference in proportion between LUM 100 mg and NAP+OME will be tested at a 5% two sided level using a Cochran-Mantel-Haenszel test stratified by country. | — |
Countries
United Kingdom
Outcome results
None listed