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Response to Supplement and Placebo in GERD
The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.
Details
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2013-06 |
| Completion | 2014-04 |
Conditions
- Gastroesophageal Reflux Disease (GERD)
- Heartburn
- Dyspepsia
Interventions
- Supplement
- Placebo
- Expanded Interview
- Standard Interview
Primary outcomes
- Safety - Number of Participants Experiencing a Serious Adverse Event — 2 week follow-up
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
Countries
United States