Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Different Doses of Naronapride Vs. Placebo in Gastroparesis

NCT05621811 · View on ClinicalTrials.gov ↗

Study Summary

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Naronapride

Study Locations (20)

Florida

  • Dr Falk Investigational Site — Clearwater
  • Dr Falk Investigational Site — Doral
  • Dr Falk Investigational Site — Hollywood
  • Dr Falk Investigational Site — Maitland
  • Dr Falk Investigational Site — Miami
  • Dr Falk Investigational Site — Miami
  • Dr Falk Investigational Site — Viera

California

  • Dr Falk Investigational Site — Chula Vista
  • Dr Falk Investigational Site — Lomita

Louisiana

  • Dr Falk Investigational Site — Houma
  • Dr Falk Investigational Site — Marrero

Michigan

  • Dr Falk Investigational Site — Flint
  • Dr Falk Investigational Site — Flint

Tennessee

  • Dr Falk Investigational Site — Cordova
  • Dr Falk Investigational Site — Nashville

Kansas

  • Dr Falk Investigational Site — Topeka

Kentucky

  • Dr Falk Investigational Site — Crestview Hills

New York

  • Dr Falk Investigational Site — New York

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2023-01-03
Est. Completion 2025-12
Phase Phase 2

Sponsor

Dr. Falk Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05621811

The ClinicalTrials.gov registry entry for NCT05621811 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Falk Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05621811 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05621811 about?

NCT05621811 is a clinical study titled "Different Doses of Naronapride Vs. Placebo in Gastroparesis". This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs...

What is the current status of trial NCT05621811?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2023-01-03. Estimated completion is 2025-12.

What conditions does trial NCT05621811 study?

This clinical trial studies the following conditions: Gastroparesis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05621811?

The interventions under investigation include: Placebo (DRUG), Naronapride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05621811?

This trial is sponsored by Dr. Falk Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05621811 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial