Frequent heartburn
Conditions
Interventions
Product Code: OX17
Pharmaceutical Form: Capsule*
INN or Proposed INN: FAMOTIDINE
CAS Number: 76824356
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Pro
Sponsors
Orexo AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years (inclusive) 2. Signed informed consent 3. Frequent heartburn (2 or more episodes per week during 14 days prior to Visit 3) 4. A history of episodes of heartburn for six months or longer. 5. Diagnosis of heartburn confirmed by diagnostic questionnaire (Carlsson-Dent) 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: 1. Ongoing Helicobacter pylori infection 2. Heartburn induced by stress, alcohol or exercise 3. Any intake of alcohol within the previous 24 hours before pH measurements and during the pH measurement periods 4. Any use of nicotine within the previous six months 5. Any drug abuse 6. Use of prescription medication within the previous 14 days or use of prescription medication which based on the terminal half-life may still be present systematically at the pre-study visit. With the exception of - contraceptives, - post- menopausal oestrogen treatments, - allergy medications for treatments of common allergic symptoms as judged by the investigator, - thyroid substitution hormones, - low dose anti-depressive treatments, - treatments of mild hypertension or hyperlipidemia as judged by the investigator, - treatment of diabetes mellitus type 1 and type 2, - medication with a written prescription though available as OTC 7. Any use of proton pump inhibitor or histamine H2-antagonist within the previous 28 days before study drug administration (Visit 3). 8. Use of any antibiotics within 4 weeks before screening visit (Visit 2). 9. History of irritable bowel syndrome. 10. Established or suspected cardiac disease with the exception of well-controlled/medicated hypertension or hyperlipididemia. 11. Diabetes mellitus type 1 and type 2 that is not well-controlled/medicated. 12. In the investigators judgement, clinically significant abnormalities at the screening examination or in the laboratory test results 13. Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control (e.g. IUD, barrier method, oral contraceptive, abstinence). 14. Known hypersensitivity to omeprazole or famotidine 15. Administration of other investigational medication within the previous 30 days of enrolment, or use of investigational medication which based on the terminal half-life may still be present systematically at the pre-study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: - To compare the proportion of time with intragastric pH>4 during the first 12 hours after study drug administration on Day 1, between treatment with a fixed combination of famotidine 10 mg and omeprazole 20 mg (OX17) and with mono-treatment with omeprazole 20 mg. The primary variable is the proportion of time with intragastric pH>4 during the first 12 hours after study drug administration on Day 1;Secondary Objective: Secondary objectives: - To compare time to pH>4 on Day 1 between treatment with a fixed combination of famotidine 10 mg and omeprazole 20 mg (OX17) and with mono-treatment with omeprazole 20 mg. The variable is pH>4. - To compare the 24-hour intragastric pH profile (acid-suppressive effect) between treatment with a fixed combination of famotidine 10 mg and omeprazole 20 mg (OX17), mono-treatment with famotidine 10 mg and omeprazole 20 mg. The pH profile of the treatments will be evaluated, tested and compared using variables derived from the 24-hour pH-metry. - To assess and compare the efficacy of each study treatment with regard to the need for antacid rescue medication during the treatment periods. - To assess tolerability and safety of treatments - To assess symptoms during treatment (patient diary 2) and baseline (patient diary 1);Primary end point(s): Primary endpoint: pH registration samples every 4 seconds after drug administration and for 24 hours. | — |
Countries
Sweden
Outcome results
None listed