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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2022
  • participants needed
    280
  • sponsor
    Neurogastrx, Inc.
Updated on 28 July 2021
nausea
abdominal pain
vomiting
obstruction
breath test
early satiety

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.

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) compared with placebo in participants with diabetic or idiopathic gastroparesis.

The study will enroll approximately 280 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.

Details
Condition Diabetic Gastroparesis, Idiopathic Gastroparesis
Treatment NG101
Clinical Study IdentifierNCT04303195
SponsorNeurogastrx, Inc.
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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