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 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT04303195
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with diabetic or idiopathic gastroparesis
* Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
* Documented evidence of no mechanical obstruction
* Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test
Exclusion Criteria:
* Uncontrolled diabetes (defined as HgbA1c \> 10%)
* Severe postural symptoms or evidence of unexplained recurrent dizziness
* Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms
* Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
* Participant engages in daily recreational use of marijuana
* Prolactin levels \> 2 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04303195
Study Brief:
Protocol Section:
NCT04303195