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This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3355 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug | Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary | Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) | Run-in period of 8-12 days and treatment period of 26-30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Silberg, MD | AstraZeneca | Study Director |
| Nimish Vakil, MD | Aurora Health Center/Waukesha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Athens | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27712711 | Derived | Ryden A, Leavy OC, Halling K, Stone AA. Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy. Value Health. 2016 Sep-Oct;19(6):829-833. doi: 10.1016/j.jval.2016.05.007. Epub 2016 Jun 29. | |
| 25304129 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD3355 | AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed |
| FG001 | Placebo | Placebo capsules twice daily, Gelusil tablets as rescue medication if needed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | capsule. administered as a single dose twice daily for 4 weeks |
|
| Gelusil® | Drug | Chewable tablets taken as needed |
|
| Tucson |
| Arizona |
| United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Sherwood | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Monterey | California | United States |
| Research Site | Murrieta | California | United States |
| Research Site | Orange | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Pueblo | Colorado | United States |
| Research Site | Boynton Beach | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Jupiter | Florida | United States |
| Research Site | Lauderdale Lakes | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | New Smyrna Beach | Florida | United States |
| Research Site | Pembroke Pines | Florida | United States |
| Research Site | Port Orange | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Zephyrhills | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Stockbridge | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Arkansas City | Kansas | United States |
| Research Site | Newton | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Madisonville | Kentucky | United States |
| Research Site | Monroe | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Chevy Chase | Maryland | United States |
| Research Site | Columbia | Maryland | United States |
| Research Site | Elkridge | Maryland | United States |
| Research Site | Hollywood | Maryland | United States |
| Research Site | Brockton | Massachusetts | United States |
| Research Site | Chesterfield | Michigan | United States |
| Research Site | Biloxi | Mississippi | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | Jefferson City | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Great Neck | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Asheville | North Carolina | United States |
| Research Site | Elkin | North Carolina | United States |
| Research Site | Fayetteville | North Carolina | United States |
| Research Site | Greensboro | North Carolina | United States |
| Research Site | Harrisburg | North Carolina | United States |
| Research Site | Morgantown | North Carolina | United States |
| Research Site | Wilmington | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Akron | Ohio | United States |
| Research Site | Canton | Ohio | United States |
| Research Site | Norman | Oklahoma | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Duncansville | Pennsylvania | United States |
| Research Site | Harrisburg | Pennsylvania | United States |
| Research Site | Sayre | Pennsylvania | United States |
| Research Site | Cranston | Rhode Island | United States |
| Research Site | Anderson | South Carolina | United States |
| Research Site | Simpsonville | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Germantown | Tennessee | United States |
| Research Site | Jackson | Tennessee | United States |
| Research Site | Johnson City | Tennessee | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Ogden | Utah | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Chesapeake | Virginia | United States |
| Research Site | Christiansburg | Virginia | United States |
| Research Site | Newport News | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Waukesha | Wisconsin | United States |
| Research Site | West End | Wisconsin | United States |
| Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177. |
| 23919738 | Derived | Ryden A, Denison H, Karlsson M, Vakil N. Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors. Scand J Gastroenterol. 2013 Sep;48(9):1018-26. doi: 10.3109/00365521.2013.822544. Epub 2013 Aug 6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD3355 | AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed |
| BG001 | Placebo | Placebo capsules twice daily, Gelusil tablets as rescue medication if needed |
| 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 | Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary | Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) | None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format. | Posted | Number | participants | Run-in period of 8-12 days and treatment period of 26-30 days |
|
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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 | AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed | 1 | 18 | ||||
| EG001 | Placebo | Placebo capsules twice daily, Gelusil tablets as rescue medication if needed | 2 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Hemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| |
| Suicide Attemp | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 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 |
|
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 prior to 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 |
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| ID | Term |
|---|---|
| C545087 | lesogaberan |
| C036656 | Gelusil |
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| Male |
|