EUCTR2006-006726-26-SE进行中（未招募）不适用
An open-label randomised observer-blind study to evaluate 24-hour intragastric pH profile at day 1 and day 14 during treatment with a fixed combination of a histamine type 2 receptor antagonist and a proton pump inhibitor
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Orexo AB
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 screeningexamination 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.
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