Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
Lead Sponsor:
Neurogastrx, Inc.
Conditions:
Diabetic Gastroparesis
Idiopathic Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2023
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04303195
Start Date
August 1 2020
End Date
February 25 2023
Last Update
August 28 2025
Active Locations (83)
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1
Digestive Health Specialists
Dothan, Alabama, United States, 36305
2
G & L Research, LLC
Foley, Alabama, United States, 36535
3
East View Medical Research
Mobile, Alabama, United States, 36606
4
Phoenix Medical Group
Peoria, Arizona, United States, 85381