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The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | AZD3355 30 mg |
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| B | Experimental | AZD3355 90 mg |
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| C | Experimental | AZD3355 120 mg |
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| D | Experimental | AZD3355 240 mg |
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| E | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug | 30 mg orally in the morning and 30 mg in the evening for 1 day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Reflux Episodes During 24 Hours | Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline) | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Acid Reflux Episodes | Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s. | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
| Number of Weakly Acidic Reflux Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Miner | Oklahoma Foundation of Digestive Research | Principal Investigator |
| Debra G Silberg | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oklahoma City | Oklahoma | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25407279 | Derived | Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J. Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study. BMC Gastroenterol. 2014 Nov 18;14:188. doi: 10.1186/1471-230X-14-188. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First 30mg, Then 90mg, Then 120mg, Then Placebo | Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period. |
| FG001 | First 30mg, Then 90mg, Then Placebo, Then 120mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention |
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| AZD3355 |
| Drug |
90 mg orally in the morning and 90 mg in the evening for 1 day |
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| AZD3355 | Drug | 120 mg orally in the morning and 120 mg in the evening for 1 day |
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| AZD3355 | Drug | 240 mg orally in the morning and 240 mg in the evening for 1 day |
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| placebo | Drug | Placebo capsules orally in the morning and placebo capsules in the evening for 1 day |
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Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s. |
| Measured during 24 hours at 4 different visits with a 7-28 days interval between |
| Number of Weakly Alkaline Reflux Episodes | Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s. | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period. |
| FG002 | First 120mg, Then Placebo, Then 240mg, Then 90mg | Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period. |
| FG003 | First Placebo, Then 30mg, Then 90mg, Then 120mg | Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period. |
| FG004 | First 90mg, Then Placebo, Then 120mg, Then 240mg | Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period. |
| FG005 | First Placebo, Then 240mg, Then 90mg, Then 30mg | Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period. |
| FG006 | First 90mg, Then 120mg, Then Placebo, Then 240mg | Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period. |
| FG007 | First 120mg, Then 30mg, Then 240mg, Then Placebo | Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period. |
| FG008 | First 240mg, Then 30mg, Then 90mg, Then Placebo | Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period. |
| FG009 | First Placebo, Then 120mg, Then 30mg, Then 240mg | Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 - First Washout Period |
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| Period 3 - Second Intervention |
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| Period 4 - Second Washout Period |
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| Period 5 - Third Intervention |
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| Period 6 - Third Washout Period |
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| Period 7 - Fourth Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all groups randomized to one of 10 sequences of drug or placebo. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Total Number of Reflux Episodes During 24 Hours | Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline) | Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period. | Posted | Geometric Mean | 95% Confidence Interval | Episodes | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
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| Secondary | Number of Acid Reflux Episodes | Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s. | Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period. | Posted | Geometric Mean | 95% Confidence Interval | Episodes | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
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| Secondary | Number of Weakly Acidic Reflux Episodes | Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0-6.5 lasting more than 5 s. | Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period. | Posted | Geometric Mean | 95% Confidence Interval | Episodes | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
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| Secondary | Number of Weakly Alkaline Reflux Episodes | Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s. | Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period. | Posted | Median | Full Range | Episodes | Measured during 24 hours at 4 different visits with a 7-28 days interval between |
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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 30 mg | a morning and an evening dose of AZD3355 30 mg | 0 | 19 | 0 | 19 | ||
| EG001 | AZD3355 90 mg | a morning and an evening dose of AZD3355 90 mg | 0 | 21 | 1 | 21 | ||
| EG002 | AZD3355 120 mg | a morning and an evening dose of AZD3355 120 mg | 0 | 21 | 0 | 21 | ||
| EG003 | AZD3355 240 mg | a morning and an evening dose of AZD3355 240 mg | 1 | 20 | 3 | 20 | ||
| EG004 | Placebo | a morning and an evening dose of placebo | 0 | 26 | 2 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritisviral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.0 |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 |
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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 |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C545087 | lesogaberan |
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a morning and an evening dose of AZD3355 240 mg
| OG004 | Placebo | a morning and an evening dose of placebo |
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| OG004 | Placebo | a morning and an evening dose of placebo |
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| OG004 | Placebo | a morning and an evening dose of placebo |
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