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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2006-000257-22-GB |
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Date of registration:
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05/05/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study to assess the effectiveness of esomeprazole 40 mg once daily in subjects with continuing gastroesophageal reflux disease (GORD) symptoms following treatment with a previous full dose proton pump inhibitor (PPI). An 8 week, open label, multicentre study. - RESPONSE study
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Scientific title:
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A study to assess the effectiveness of esomeprazole 40 mg once daily in subjects with continuing gastroesophageal reflux disease (GORD) symptoms following treatment with a previous full dose proton pump inhibitor (PPI). An 8 week, open label, multicentre study. - RESPONSE study |
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Date of first enrolment:
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03/07/2006 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000257-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Signed and dated informed consent will be obtained before any study related procedure is conducted.
2. Male or female aged ³ 18 years
3. Current treatment for GORD with a PPI at a full dose, given once daily, for a period of up to 8 weeks
4. Persisting GORD symptoms of heartburn, acid regurgitation or epigastric pain during the past 7 days prior to visit 1, judged by the subject as either:
· 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)
· 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
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:
presence of one or more of these criteria will exclude the patient
1. More than 1 previous course of full dose PPI in the last 12 months (excluding the current course)
2. Current treatment for GORD with a full dose PPI for more than 8-weeks
3. Previous use of esomeprazole
4. Subjects using an H2 receptor antagonist (either prescribed or OTC)
5. Documented medical history or gastrointestinal pathology such as:
· Gastrointestinal malignancy
· Zollinger-Ellison syndrome; malabsorption
· Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study
· Unstable diabetes mellitus as judged by the investigator to interfere with the evaluation of the study
6. Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: Previous lower gastrointestinal surgery such as appendectomy, colonic resection, cholecystectomy, or gynaecological surgery are not exclusion criteria
7. Presence of Irritable Bowel Syndrome as judged by the investigator. This is characterised by chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating·
8. Presence of any alarm symptoms suggestive of organic disease, including but not limited to, vomiting, GI bleeding or anaemia, abdominal mass, unexplained weight loss and dysphagia
9. Severe, concurrent disease or mental illness that may complicate the study evaluation or affect subject compliance as judged by the Investigator
10. Requirement for continuous concurrent therapy with the following medications during the study period:
Sucralfate, quinidine, warfarin and other vitamin K antagonists, phenytoin, bisphosphonates, methotrexate, antidepressants (therapy less than 3 days per week is acceptable), prostaglandin analogues such as misoprostol, ketoconazole, fluconazole, itraconazole, diazepam, cisapride
11. Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test and maintain contraception during the study medication treatment period. Investigators should be satisfied that those women who are not surgically sterilized or are < 1 year post-menopausal are not pregnant at study entry. Any contraceptive measure with a less than 1% failure rate will be considered acceptable (birth control pill, IUD, Depo-Provera®) or double-barrier method (e.g. condom and spermicide, diaphragm and contraceptive foam).
12. Chronic alcoholism, drug abuse, or psychological condition judged by the investigator to potentially result in poor subject compliance or interfere with study evaluation.
13. Suspected or confirmed current malignancy except basal cell carcinoma. Current is defined as: any malignancy, except basal cell carcinoma, that has been active within the previous 12 months
14. Known hypersensitivity to esomeprazole or any of its constituents
15. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
16. Previous enrolment or randomisation of treatment in the present
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux Disease (GORD)
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Intervention(s)
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Product Name: Nexium (esomeprazole)
Product Code: Nexium (esomeprazole)
Pharmaceutical Form: Tablet
INN or Proposed INN: esomeprazole
CAS Number: 161796-78-7
Current Sponsor code: N/A
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
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Primary Outcome(s)
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Primary end point(s): Change in frequency of heartburn from baseline value at entry to the end of the study.
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Secondary Objective: The secondary objectives of the study are to assess the:
- Change in frequency of heartburn after 4 weeks treatment from baseline value at entry into the study
- Change in severity of heartburn after 4 and 8 weeks treatment from baseline value at entry into the study
- Change in severity and frequency of epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline values at entry into the study.
- Change in symptom control on Esomeprazole 40mg from baseline to 4 and 8 weeks using the Reflux Disease Questionnaire (RDQ)
- Symptom control, defined as more symptom free days, as assessed by the GORD Impact Scale (GIS) at weeks 4 and 8.
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Main Objective: The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with Esomeprazole 40mg compared to previous full dose treatment with a PPI given once daily.
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Secondary ID(s)
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D9612L00104
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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