E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will be using Nexium to treat gastro-oesophageal reflux and in return this will reduce reflux related cough ( a manifestation of reflux) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 3 |
E.1.2 | Level | 2 |
E.1.2 | Classification code | 10013946 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective of this study is to demonstrate that esomeprazole (20 mg, twice daily, given for 8 weeks) is superior to placebo in the treatment of chronic cough due to reflux, with respect to the daily diary cough index |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to demonstrate that esomeprazole (20 mg, twice daily, given for 8 weeks) is superior to placebo in the improvement of symptoms (cough specific LPR score), The Leicester cough score and the subjects overall assessment of treatment. Changes in spirometry, cough challenge, methacholine challenge and laryngoscopy reflux score will also be compared between treatments.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable will be the change in cough index ( derived from daily diary assessments of the severity of cough score by taking the average score over the final 14 days of treatment) in patients on 8 weeks treatment with esomeprazole 20 mg BD compared with patients on 8weeks treatment with placebo. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of the trial will be defined as patient number 50 having completed all procedures pertaining to the final visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |