E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gastroesophageal reflux disease (GERD)
or
Non Erosive Reflux Disease (NERD) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017885 |
E.1.2 | Term | Gastrooesophageal reflux disease |
|
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 |
To compare the effect of 40 mg pantoprazole on heartburn assessed by the physician, on the one hand, and on GERD- related symptoms assessed by the patient and documented in ReQuest™, on the other. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Written informed consent · Aged at least 18 years · History of GERD-related symptoms of at least 6 months prior to B0 · Heartburn on at least 3 days within the last 7 days prior to B0 as assessed by the investigator · Acid complaints on at least 3 days within the last 7 days prior to B0 as assessed by the investigator · Endoscopically confirmed GERD A - D classification determined via the Los Angeles classification system or symptom-based diagnosis of NERD |
|
E.4 | Principal exclusion criteria |
· Zollinger-Ellison syndrome or any other gastric hypersecretory condition · previous acid-lowering surgery or any other surgery of the oesophagus and / or upper gastrointestinal tract, with the exception of polyectomy and cholecystectomy · presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett’s oesophagus with known high-grade dysplasia or longer than 3 cm · acute peptic ulcer and / or ulcer complications · pyloric stenosis · inflammatory bowel diseases · severe or unstable cardiovascular, pulmonary and / or endocrine disease, clinically significant renal or hepatic disease or dysfunction, haematological disorder, severe psychiatric or neurological disorders or any other clinically significant condition · malignancy of any kind within 5 years prior to B0, with the exception of successfully treated basal or squamous cell cancer of the skin · known or suspected hypersensitivity to the study medication · known or suspected alcohol or drug abuse within 1 year prior to B0 · clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation, as assessed by the investigator · pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential · any medication for the purpose of the eradication of Helicobacter pylori within the last 28 days prior to B0 · systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days within the last 28 days prior to B0, with the exception of acetylsalicylic acid not more than 150 mg per day
· dyspepsia-inducing drugs for more than 3 consecutive days within the last 7 days prior to B0 · use of any other non-allowed drug · wash-out times of non-allowed drugs cannot be adhered to · participation in another study within 30 days preceding visit B0 and during the present study · previous enrolment into the treatment period of the current study · patients who are expected to be non-compliant and or non-cooperative or who not able to follow the procedures of the study due to for instance language problems or psychological disorders
Concomitant medication The use of the following medication is not allowed:
· PPIs, with the exception of the study medication, H2-receptor antagonists, prokinetics, sulcralfate, bismuth preparations or any other substance that may have an influence on the relief of acid-related symptoms, with the exception of antacids · Any medication for the purpose of the eradication of H. pylori · Systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days, with the exception of acetylsalicylic acid less than 150 mg per day · Ketoconazole or any other drug with pH-dependent absorption · dyspepsia-inducing drugs for more than 3 consecutive days |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The misclassification rate as defined below. For each patient the following two assessments will be made: Heartburn as assessed by the investigator and symptom assessment by ReQuest™-GI.
A patient will be defined as misclassified if one of the following two statements is true: · The patient is below the predefined ReQuest™-GI GERD symptom threshold (i.e., 1.60 based on the 95% percentile, Stanghellini et al., 2006) on all of the 3 consecutive days prior to day 14 and is not free from heartburn (as assessed by the investigator) on all of the 7 consecutive days prior to day 14. · The patient is above the predefined ReQuest™-GI GERD symptom threshold on all of the 3 consecutive days prior to day 14 and is free from heartburn (as assessed by the investigator) on all of the 7 consecutive days prior to day 14.
|
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |