Trial | NCT04303195  Report issue

Title

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    NG101 ...

  • Study Participants

    162
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.
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 placebo in participants with diabetic or idiopathic gastroparesis.

The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.
Study Started
Aug 01
2020
Primary Completion
Feb 25
2023
Study Completion
Feb 25
2023
Last Update
Mar 28
2023

Drug NG101

Capsules

  • Other names: metopimazine mesylate

Drug Placebo

Capsules

NG101 - 5 mg Experimental

NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

NG101 - 10 mg Experimental

NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

NG101 - 20 mg Experimental

NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

Placebo Placebo Comparator

Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks

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
No Results Posted