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A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
Phase 2
Waitlist Available
Research Sponsored by Neurogastrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Summary
This trial tests NG101, a medication for adults with gastroparesis, to see if it helps their stomachs empty food better and reduces symptoms like nausea.
Eligible Conditions
- Gastroparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of Severity of Nausea
Incidence and severity of Adverse Events
Secondary study objectives
Change from Baseline
Change from Baseline of Symptoms
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NG101 - 5 mgExperimental Treatment1 Intervention
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group II: NG101 - 20 mgExperimental Treatment1 Intervention
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group III: NG101 - 10 mgExperimental Treatment1 Intervention
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group IV: PlaceboPlacebo Group2 Interventions
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NG101
2024
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
Neurogastrx, Inc.Lead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Stephen Wax, MDStudy DirectorNeurogastrx, Inc.