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

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ClinicalTrials.gov Identifier: NCT04303195
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Neurogastrx, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Idiopathic Gastroparesis Drug: NG101 Phase 2

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) 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NG101 - 5 mg
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
 Drug: NG101
Capsules
Other Name: metopimazine
Experimental: NG101 - 10 mg
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
 Drug: NG101
Capsules
Other Name: metopimazine
Experimental: NG101 - 20 mg
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
 Drug: NG101
Capsules
Other Name: metopimazine
Placebo Comparator: Placebo
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
 Drug: NG101
Capsules
Other Name: metopimazine


Outcome Measures
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Primary Outcome Measures :
  1. Change of Severity of Nausea [ Time Frame: Baseline to Week 12 ]
    Change from Baseline at weeks 7 through12 as measured by patient's daily diary entries during participation in the study.

  2. Incidence and severity of Adverse Events [ Time Frame: Baseline to Week 12 ]
    Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)


Secondary Outcome Measures :
  1. Change from Baseline of Symptoms [ Time Frame: Baseline to Week 12 ]
    Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for number of discrete episodes of vomiting.

  2. Change from Baseline of Symptoms [ Time Frame: Baseline to Week 12 ]
    Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for early satiety severity score.

  3. Change from Baseline [ Time Frame: Baseline to Week 12 ]
    Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

  4. Change from Baseline [ Time Frame: Baseline to Week 12 ]
    Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for abdominal pain severity score.

  5. Change from Baseline [ Time Frame: Baseline to Week 12 ]
    Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for total severity score (nausea, early satiety, postprandial fullness, abdominal pain).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303195


Contacts
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Contact: Neurogastrx, Inc. Sponsor 781-730-4040 info@neurogastrx.com

Locations
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Sponsors and Collaborators
Neurogastrx, Inc.
Investigators
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Study Director: Stephen Wax, MD Neurogastrx, Inc.
More Information
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Responsible Party: Neurogastrx, Inc.
ClinicalTrials.gov Identifier: NCT04303195    
Other Study ID Numbers: NG101-201
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
 Metopimazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents