Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No 2006-003541-16 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment | Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary | Twice daily during the last seven days on treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule | An interval of one to two hours after the first intake of AZD3355 65 mg capsule |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Göran Hasselgren, MD | AstraZeneca | Study Director |
| Guy Boeckxstaens, MD | Academisch Medisch Centrum Universiteit van Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Adelaide | Australia | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21402616 | Derived | Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Bjorck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD3355 | AZD3355 capsules 65 mg bid |
| FG001 | Placebo | Placebo capsules bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brussels |
| Belgium |
| Research Site | Eupen | Belgium |
| Research Site | Wilrijk | Belgium |
| Research Site | Alès | France |
| Research Site | Angers | France |
| Research Site | Bordeaux | France |
| Research Site | Lyon | France |
| Research Site | Nantes | France |
| Research Site | Cologne | Germany |
| Research Site | Koblenz | Germany |
| Research Site | Ludwigshafen | Germany |
| Research Site | München | Germany |
| Research Site | Oelde | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Wangen | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Nagykanizsa | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Szombathely | Hungary |
| Research Site | Vác | Hungary |
| Research Site | Amsterdam | Netherlands |
| Research Site | Ålesund | Norway |
| Research Site | Bergen | Norway |
| Research Site | Levanger | Norway |
| Research Site | Oslo | Norway |
| Research Site | Rud | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Tromsø | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Satu Mare | Romania |
| Research Site | Târgu Mureş | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD3355 | AZD3355 capsules 65 mg bid |
| BG001 | Placebo | Placebo capsules bid |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment | Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary | Posted | Number | Participants | Twice daily during the last seven days on treatment |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule | Posted | Mean | Standard Deviation | μmol/L | An interval of one to two hours after the first intake of AZD3355 65 mg capsule |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD3355 | AZD3355 capsules 65 mg bid | 2 | 28 | ||||
| EG001 | Placebo | Placebo capsules bid | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
AZ shall have 30 days from the proposed final manuscript for any disclosure to review it and may within such time require that submission for publication/disclosure be delayed in order for AZ to file patent applications. If study site/investigator requests permission to publish data(incl oral presentations) it is to be agreed with AZ before publ.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C545087 | lesogaberan |
Not provided
Not provided
Not provided
| Male |
|
|