A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurogastrx, Inc.
• Treatments: Metopimazine

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