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NCT04303195 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
A Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, sponsored by Neurogastrx.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT04303195: Completed Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, sponsored by Neurogastrx.
NCT04303195 is a Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis that has completed, run by Neurogastrx. The registered enrollment target is 161 participants, above the 138-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303195, a Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, has completed, sponsored by Neurogastrx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NG101
Study Locations (20)
California
- GW Research, Inc - Chula Vista
- Precision Research Institute, LLC - Chula Vista
- Kindred Medical Institute for Clinical Trials, LLC - Corona
- Diagnamics Inc. - Encinitas
- Paragon Rx Clinical, Inc - Garden Grove
- United Clinical Research - Irvine
- Prime Care Clinical Rsearch - Laguna Hills
- Torrance Clinical Research Institute, Inc. - Lomita
- Angel City Research - Los Angeles
- United Clinical Research - Murrieta
- Diabetes Medical Center of California - Northridge
- Precision Research Institute - San Diego
Alabama
- Digestive Health Specialists - Dothan
- G & L Research, LLC - Foley
- East View Medical Research - Mobile
Arizona
- Phoenix Medical Group - Peoria
- Phoenix Clinical LLC - Phoenix
- Del Sol Research Management - Tucson
Arkansas
- Preferred Research Partners - Little Rock
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2023-02-25 |
| Phase | Phase 2 |
What the finished NCT04303195 record still lists
NCT04303195 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 138-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (17% higher).
The record links to 2 conditions, with Diabetic Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04303195 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04303195 about?
NCT04303195 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis". 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.
What is the current status of trial NCT04303195?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2020-08-01. Estimated completion is 2023-02-25.
What conditions does trial NCT04303195 study?
This clinical trial studies the following conditions: Diabetic Gastroparesis, Idiopathic Gastroparesis.
What interventions are being tested in trial NCT04303195?
The interventions under investigation include: Placebo (DRUG), NG101 (DRUG).
Who is sponsoring clinical trial NCT04303195?
This trial is sponsored by Neurogastrx, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04303195 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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