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The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD3355 |
|
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3355 | Drug | 65 mg capsules, oral, 3 single doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose | The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133). The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment. | 0-3 hours post meal, post third dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number Reflux Episodes 0-24 Hours Post First Dose | Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording. | 0-24 hours |
| Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Ersdal, PhD | AstraZeneca R&D, Mölndal, Sweden | Study Director |
| Daniel Sifrim, MD, PhD | Center for Gastroenterological Research, Belgium | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20451523 | Derived | Boeckxstaens GE, Beaumont H, Mertens V, Denison H, Ruth M, Adler J, Silberg DG, Sifrim D. Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease. Gastroenterology. 2010 Aug;139(2):409-17. doi: 10.1053/j.gastro.2010.04.051. Epub 2010 May 5. |
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42 patients in 2 countries were enrolled in the study. 27 patients were randomised to treatment. 2 patients discontinued prematurely, 1 due to low Lower Esophageal Sphincter Pressure (LESP)/catheter placement problems, and 1 due to nausea/vomiting. Thus, 25 patients completed the study, 10 in Belgium and 15 in the Netherlands.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD3355 First, Then Placebo | 65 mg drug or placebo capsules, oral, 3 single doses |
| FG001 | Placebo First, Then AZD3355 | 65 mg drug or placebo capsules, oral, 3 single doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to received Drug first and Placebo first. |
| 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 |
| 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 Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose | The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133). The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment. | Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing. | Posted | Geometric Mean | 95% Confidence Interval | Relaxations | 0-3 hours post meal, post third dose |
|
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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 | 65 mg drug capsules, oral, 3 single doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C545087 | lesogaberan |
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| Placebo | Drug | capsules, oral, 3 single doses |
|
The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here. |
| 0-12 hours post first dose |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG000 | AZD3355 | 65 mg drug capsules, oral, 3 single doses |
| OG001 | Placebo | placebo capsules, oral, 3 single doses |
|
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| Secondary | Total Number Reflux Episodes 0-24 Hours Post First Dose | Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording. | Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time. | Posted | Geometric Mean | 95% Confidence Interval | Episodes | 0-24 hours |
|
|
|
| Secondary | Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method. | The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here. | Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2. | Posted | Geometric Mean | Standard Deviation | μmol*hours / L | 0-12 hours post first dose |
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| 0 |
| 25 |
| 16 |
| 25 |
| EG001 | Placebo | placebo capsules, oral, 3 single doses | 0 | 27 | 18 | 27 |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Feeling Hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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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.
| D004066 | Digestive System Diseases |