Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT00321503
Eligibility Criteria:
INCLUSION CRITERIA:
Group 1 (negative control):
* RSI ≤ 13
* No history of voice or swallowing disorders
* No active voice or swallowing disorders
* No history of heartburn, regular indigestion, and no prior or current diagnosis of GERD
Groups 2 and 3 (experimental group):
* Clinical symptoms consistent with LPR as measured by an RSI \> 13.
* No other voice or swallowing pathology on clinical exam
EXCLUSION CRITERIA:
* Regular treatment with an H2 blocker or proton pump inhibitor (PPI)
* History of laryngeal/pharyngeal surgery
* Any planned treatment of the larynx/pharynx other than treatment for LPR
* Smoking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00321503
Study Brief:
Protocol Section:
NCT00321503