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This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 mg | Experimental | PPI+lesogaberan (AZD3355) 60 mg bid |
|
| 120 mg | Experimental | PPI+lesogaberan (AZD3355) 120 mg bid |
|
| 180 mg | Experimental | PPI+lesogaberan (AZD3355) 180 mg bid |
|
| 240 mg | Experimental | PPI+lesogaberan (AZD3355) 240 mg bid |
|
| Placebo | Placebo Comparator | PPI+ Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesogaberan (AZD3355) | Drug | 60 mg, oral, capsules, bid for 4 w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | 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 Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease) | The 7 days before randomisation (baseline) and during 26-30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | 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 Symptom Questionnaire diary (GERD = Gastroesophageal Reflux Disease) | The 7 days before randomisation (baseline) and during 26-30 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Silberg, MD | AstraZeneca | Study Director |
| Nicholas Shaheen, MD, MPH | UNC Hospitals, 4141Chapel Hill, NC 27599 USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oklahoma City | Oklahoma | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23318482 | Derived | Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15. | |
| 22730470 | Derived | Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD3355 60 mg | PPI+AZD3355 60 mg twice daily (bid) |
| FG001 | AZD3355 120 mg | PPI+AZD3355 120 mg twice daily (bid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lesogaberan (AZD3355) |
| Drug |
120 mg, oral, capsules, bid for 4 w |
|
| lesogaberan (AZD3355) | Drug | 180 mg, oral, capsules, bid for 4 w |
|
| lesogaberan (AZD3355) | Drug | 240 mg, oral, capsules, bid for 4 w |
|
| Placebo | Drug | oral,capsules, bid for 4 w |
|
| FG002 |
| AZD3355 180 mg |
PPI+AZD3355 180 mg twice daily (bid) |
| FG003 | AZD3355 240 mg | PPI+AZD3355 240 mg twice daily (bid) |
| FG004 | Placebo | PPI+Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD3355 60 mg | PPI+AZD3355 60 mg twice daily (bid) |
| BG001 | AZD3355 120 mg | PPI+AZD3355 120 mg twice daily (bid) |
| BG002 | AZD3355 180 mg | PPI+AZD3355 180 mg twice daily (bid) |
| BG003 | AZD3355 240 mg | PPI+AZD3355 240 mg twice daily (bid) |
| BG004 | Placebo | PPI+Placebo |
| BG005 | 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 a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation) | 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 Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease) | Posted | Number | Participants | The 7 days before randomisation (baseline) and during 26-30 days of treatment |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms. | 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 Symptom Questionnaire diary (GERD = Gastroesophageal Reflux Disease) | Posted | Median | Inter-Quartile Range | Percent | The 7 days before randomisation (baseline) and during 26-30 days of treatment |
|
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As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD3355 60 mg | PPI+AZD3355 60 mg twice daily (bid) | 0 | 13 | ||||
| EG001 | AZD3355 120 mg | PPI+AZD3355 120 mg twice daily (bid) | 0 | 12 | ||||
| EG002 | AZD3355 180 mg | PPI+AZD3355 180 mg twice daily (bid) | 0 | 16 | ||||
| EG003 | AZD3355 240 mg | PPI+AZD3355 240 mg twice daily (bid) | 1 | 20 | ||||
| EG004 | Placebo | PPI+Placebo | 1 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Cardiac Chest Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Metastatic Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 |
|
There is an agreement between PI and Sponsor (AZ) or its agents that restricts the PI's right to discuss/publish trial results after the trial is completed.The PI agrees to collaborate in good faith with AZ with regards to content and formation of any publication or disclosure to be made by PI and to pay due consideration to opinions offered by AZ.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@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 |
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| ID | Term |
|---|---|
| C545087 | lesogaberan |
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| Male |
|
PPI+Placebo
|
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