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NG101 for Gastroparesis

Phase 2
Waitlist Available
Research Sponsored by Neurogastrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

Study Summary

This trial is testing a new drug, NG101, to see if it is safe and effective in treating gastroparesis.

Eligible Conditions
  • Gastroparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Severity of Nausea
Incidence and severity of Adverse Events
Secondary outcome measures
Change from Baseline
Change from Baseline of Symptoms

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NG101 - 5 mgExperimental Treatment1 Intervention
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group II: NG101 - 20 mgExperimental Treatment1 Intervention
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group III: NG101 - 10 mgExperimental Treatment1 Intervention
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Group IV: PlaceboPlacebo Group2 Interventions
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NG101
2020
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Neurogastrx, Inc.Lead Sponsor
Stephen Wax, MDStudy DirectorNeurogastrx, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open and willing to enroll participants?

"According to clinicaltrials.gov, this particular research trial is not currently recruiting patients even though it was initially posted on August 1st 2020 and last updated on November 4th 2022. However, 30 other medical studies are presently searching for individuals who may be interested in participating in a clinical trial."

Answered by AI

What dangers have been identified in relation to the use of NG101?

"The safety of the drug NG101 is estimated to be a 2 on a scale from 1 to 3. This is owing to its position in Phase 2 trials, where there are some data indicating its safety but none yet that demonstrate efficacy."

Answered by AI

Has this type of clinical trial been conducted previously?

"Since 2020, NG101 has been subject to research. Neurogastrx, Inc., the original sponsor of a clinical trial involving 140 participants in 2020, moved the drug through Phase 2 approval afterwards. Presently, there is only one active study for this compound being hosted by Neurogastrx."

Answered by AI

How many participants are being enlisted for this trial?

"This trial is no longer accepting participants. Initially published on August 1st 2020, the last update was November 4th 2022. If you are in pursuit of other studies, there are currently 29 trials recruiting for gastroparesis and a single NG101 study looking for volunteers."

Answered by AI

How many healthcare facilities are actively participating in this clinical trial?

"This trial is being conducted from 83 different medical locations, with a few of the more prominent sites located in Dayton, Topeka and San Antonio. When considering enrollment for this study, it is important to choose the nearest site in order to reduce any necessary travel."

Answered by AI

Has NG101 been studied in any previous research?

"In 2020, Rio Grande Gastroenterology launched clinical trials for NG101. To date, there are 18326 completed studies and 1 active trial occurring in Dayton, Ohio."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Texas
Massachusetts
Other
How old are they?
65+
18 - 65
What site did they apply to?
Del Sol Research Management
Aa Mrc Llc
Beth Israel Deaconess Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
2020. "A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04303195.
~35 spots leftby Apr 2025
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