Phase 2
N=478
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
GERD · Acid Reflux Disease · Heartburn · Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT00703534 ↗Enrolled (actual)
478
Serious AEs
—
Results posted
Jun 2011
Primary outcome: Primary: Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD3355 (Drug); Placebo (Drug); Gelusil® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary |
— | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00703534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.