A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d.

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-005169-39-GB
• Date of registration: 15/06/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d.
• Scientific title: A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d.
• Date of first enrolment: 26/10/2005
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005169-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Single arm If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Germany, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
1. Subjects must have provided informed consent in writing for the participation in this study
2. Subjects aged 18 to 79 years inclusive, male or female
3. Subjects who seek medical advice in primary care for symptoms thought by the PCP to arise from the upper GI tract (any of those symptoms listed in Table 3)
4. The symptoms thought to pertain to the upper GI tract must have been present for at least 4 weeks prior to Visit 1 and to have occurred at least twice a week during that period
5. The symptoms thought to pertain to the upper GI tract must have been of at least mild severity for a minimum of 3 days during the week prior to Visit 1
6. Subjects judged to be capable to understand and to complete diaries and questionnaires reliably.

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:
Any of the following is regarded as a criterion for exclusion from the study:
1. Upper GI endoscopy performed within a year prior to Visit 1
2. Previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery
3. Contra-indication to the Bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the GI-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (NB: subjects with LA Grade D confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure)
4. Any use of PPIs within 2 months prior to Visit 1, including those obtained OTC
5. Use of the following drug therapy within 4 weeks prior to Visit 1:
- Daily use of acetylsalicylic acid (ASA) at any dose greater than 165 mg
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) including
COX-2 inhibitors at any dose
6. Presence of any alarm features, such as:
- Unintentional weight loss >3 kg in the previous 3 months
- Haematemesis, melaena or per-rectum blood loss in the previous year
- Progressive dysphagia
- Anaemia
- Any other symptom suggestive of malignancy
7. Any significant past or current disease or disorder (e.g.; cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, malignant, or psychiatric), as revealed by history, physical examination or laboratory assessments, which, in the opinion of the investigator, may put the subject at risk, alter their performance or influence the subject’s ability to participate in the study
8. Unwillingness to undergo endoscopy, esophageal pH monitoring or to complete any other standard assessments used in the study
9. History of alcohol or drug abuse in the last two years or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator
10. Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator
11. Treatment with phenytoin, warfarin (or other vitamin K antagonists), ketoconazole, itraconazole and cisapride
12. Planned donation of blood during the study period
13. Planned hospitalisation during the study period
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
15. Treatment with any medicinal investigational product within 90 days prior to Visit 1
16. Previous enrolment in the present study
17. Participation as a subject in any other medical research project during and in the 90 days prior to the start of the study
In addition to the above, the following criterion excludes the subject from participation into the study at Visit 2:
18. Any findings at endoscopy that make further participation in the study clinically inappropriate as judged by the investigator, such as suspected malignancy or evidence of clinically significant gastrointestinal bleeding (i.e. visible vessel or other stigmata of current bleeding) [NB: Subjects with macroscopic Barrett’s esophagus (defined as subjects with endoscopic indications of any columnar lined epithelium in the esophagus) are not to be excluded; Subjects with LA Grade D confirmed by endoscopy at Visit 2 can continue the study without performing the Bravo™ procedure.].



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Symptoms from the upper gastrointestinal tract

Intervention(s)

Product Name: Esomeprazole, phase III capsule
Product Code: Esomeprazole, Gastro-Resistant Capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Esomeprazole magnesium trihydrate
CAS Number: 217087-09-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: 1. To estimate the sensitivity and specificity of the selection of RDQ items, endoscopy, esophageal pH monitoring, response to proton pump inhibitors (PPIs) and Symptom Association Probability (SAP) as diagnostic tests for GERD by using Latent Class Analysis (LCA) and Bayesian statistics
2. To estimate the prevalence of GERD with LCA and Bayesian statistics
3. To describe the study population at the initial and last visit with the Gastrointestinal Symptom Rating Scale (GSRS) dimensions in the whole study population and by GERD diagnosis
4. To estimate responsiveness of the RDQ during therapy in subjects categorised as having or not having GERD

Main Objective: The primary objective of this study is to determine the accuracy of the RDQ as a diagnostic test for gastroesophageal reflux disease. Symptom evaluation by the RDQ will be compared with other established approaches to the diagnosis of GERD in a primary care patient population with symptoms thought to be of upper gastrointestinal (GI) tract origin.

Primary end point(s): There are no primary end point in this study.

Based on the selection of RDQ items and the various methods of diagnosing
GERD, i.e. presence/absence of GERD as assessed by endoscopic Los Angeles (LA) grade, pH monitoring (% time with esophageal pH<4), SAP, outcome of PPI test, the primary variables are the cut-off level(s), sensitivity, specificity and predictive abilities of the RDQ score(s) (ROC curve and c-statistic), as assessed against each other diagnostic tool in use in this study

Secondary ID(s)

2004-005169-39-SE

D9914C00002