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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01149369
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older at registration
* Gastric emptying scintigraphy within 2 years of registration
* Normal upper endoscopy or upper GI series within 2 years of registration
* Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21
* Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale
Exclusion Criteria:
* Another active disorder which could explain symptoms in the opinion of the investigator
* Use of narcotics more than 3 days per week
* Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
* Contraindications to aprepitant such as hypersensitivity or allergy
* Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride
* Pregnancy or nursing
* Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
* Failure to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149369
Study Brief:
Protocol Section:
NCT01149369