An 8 week, double-blind, randomised, parallel group study to investigate the effect of 20 mg Esomeprazole (Nexium?) tablets Twice daily versus placebo on symptoms associated with chronic cough due to reflux - Nexium in Reflux Cough

Phase 1

Active, not recruiting

• Conditions: We will be using Nexium to treat gastro-oesophageal reflux and in return this will reduce reflux related cough ( a manifestation of reflux); MedDRA version: 3 Level: 2 Classification code 10013946

• Registration Number: EUCTR2004-004748-27-GB
• Lead Sponsor: Hull and east Yorkshire Hospitals Trust, Research and Deveopment, admin porta cabin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients of either sex who meet the following criteria will be considered for inclusion in the study.

? Written informed consent
? Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-esophageal reflux.
? Male and female subjects of at least 18 yrs of age
? Subjects able to understand the study and co-operate with the study procedures
? Subjects who consent to their general practitioner (GP) being informed of their study participation

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

? Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
? Suffering from any concomitant disease which may interfere with study procedures or evaluation.
? A lower respiratory tract infection 4 weeks prior to entry on to study
? Participation in another study (use of investigational product) within 30 days preceding entry on to study.
? Alcohol or drug abuse
? Inability to follow study procedures
? Use of PPI or H2 receptor antagonists (H2Ras) 4weeks prior to enrolment
? Use of Liquid alginates 2 weeks prior to enrolment
? Use of opiates to treat cough 1 week prior to enrolment.
? Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
? Subjects who have significant pathology on most recent chest X-Ray.

Study & Design

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