Acid Reflux Disease, GERD, Heartburn, Regurgitation
Conditions
Keywords
GERD, Acid Reflux, Heartburn, Regurgitation, non-acid reflux, PRO measures
Brief summary
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).
Interventions
DRUGAZD3355
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
DRUGPlacebo
capsule. administered as a single dose twice daily for 4 weeks
DRUGGelusil®
Chewable tablets taken as needed
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject able to read and write US english and able to use electronic devices * Subjects who have experienced GERD symptoms for at least six months * Subjects currently taking a prescription or over-the-counter PPI medications for GERD * Body Mass Index (BMI) 18.5-35.0, inclusive
Exclusion criteria
* Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment * Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer * Prior surgery of the upper Gastrointestinal (GI) tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary | Run-in period of 8-12 days and treatment period of 26-30 days | Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD3355 AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed | 235 |
| Placebo Placebo capsules twice daily, Gelusil tablets as rescue medication if needed | 243 |
| Total | 478 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 3 |
| Overall Study | Incorrect Enrollment | 6 | 6 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Severe Non Compliance | 1 | 5 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | AZD3355 | Placebo | Total |
|---|---|---|---|
| Age Continuous | 49.7 Years STANDARD_DEVIATION 10.09 | 47.8 Years STANDARD_DEVIATION 11.5 | 48.7 Years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 145 Participants | 135 Participants | 280 Participants |
| Sex: Female, Male Male | 90 Participants | 108 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / — | 7 / — |
| serious Total, serious adverse events | 1 / — | 2 / — |
Outcome results
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)
Time frame: Run-in period of 8-12 days and treatment period of 26-30 days
Population: 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.