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

Neurogastrx

Status and phase: Completed; Phase 2

Conditions: Diabetic Gastroparesis; Idiopathic Gastroparesis

Treatments: Drug: Placebo; Drug: NG101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04303195

NG101-201

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

162 participants in 4 patient groups, including a placebo group

NG101 - 5 mg

Experimental group

Description:

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

Treatment:

Drug: NG101

NG101 - 10 mg

Experimental group

Description:

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

Treatment:

Drug: NG101

NG101 - 20 mg

Experimental group

Description:

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

Treatment:

Drug: NG101

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo