Phase 2
Completed N=478
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
GERD · Acid Reflux Disease · Heartburn · Regurgitation
Source: ClinicalTrials.gov NCT00703534 ↗
Enrolled (actual)
478
Serious AEs
—
Results posted
Jun 2011
Primary outcomePrimary: 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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary |
— | — |
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. Informational only — not medical advice.