Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
Heartburn, Patient reported symptoms, Proton pump inhibitor
Brief summary
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.
Interventions
DRUGAZD3355
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent * At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms * Continuous treatment with Proton Pump Inhibitor (PPI) * Ability to read and write
Exclusion criteria
* Prior surgery of the upper gastrointestinal (GI) tract * History of clinically significant diseases other than GERD * Need for concomitant medication with drugs that may influence gastrointestinal symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Twice daily during the last seven days on 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 |
Secondary
| Measure | 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 |
Countries
Australia, Belgium, France, Germany, Hungary, Netherlands, Norway, Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD3355 AZD3355 capsules 65 mg bid | 122 |
| Placebo Placebo capsules bid | 122 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | incorrect enrolment | 4 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | AZD3355 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 51.1 years STANDARD_DEVIATION 11.9 | 48.7 years STANDARD_DEVIATION 12.6 | 49.9 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 51 Participants | 31 Participants | 82 Participants |
| Sex: Female, Male Male | 71 Participants | 91 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / — | 19 / — |
| serious Total, serious adverse events | 2 / — | 0 / — |
Outcome results
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
Time frame: Twice daily during the last seven days on treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD3355 | 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 | 17 Participants |
| Placebo | 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 | 8 Participants |
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
Time frame: An interval of one to two hours after the first intake of AZD3355 65 mg capsule
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD3355 | 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 | 0.96 μmol/L | Standard Deviation 0.74 |