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

• Conditions: Frequent heartburn

• Registration Number: EUCTR2006-006726-26-SE
• Lead Sponsor: Orexo AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified