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New drug offers hope for chronic stomach pain and nausea

NCT ID NCT05621811

Symptom relief Sponsor: Dr. Falk Pharma GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called naronapride in 328 adults with moderate to severe gastroparesis (stomach paralysis). Participants took either 10, 20, or 40 mg of the drug or a placebo daily for 12 weeks. The goal was to see if the drug could reduce symptoms like nausea, vomiting, and bloating better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

328 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women between ≥18 and ≤75 years of age, * Body Mass Index (BMI) ≥16 and \<35 kg/m2 , * History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months, * Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile of normative data) during the screening phase, * Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the daily symptom scores recorded for at least 5 of 7 consecutive days in the week prior to Baseline, * Participants with a type I or type II diabetes mellitus diagnosis must have a controlled diabetes mellitus defined as HbA1c ≤11% under stable antidiabetic medication, * Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy during screening phase (previous endoscopic results within 12 months are acceptable, if no relevant changes in patient's disease status occurred since that time), * No evidence of intestinal stenosis as determined by an imaging technique (i.e., either abdominal sonography, Magnetic resonance imaging \[MRI\] or imaging by computed tomography \[CT\] during screening phase (previous MRI/CT imaging or sonography results within 12 months are acceptable, if no relevant changes occurred in patient's disease status since that time), Exclusion Criteria: * History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy, * Intrapyloric botulinum toxin injection within 12 months, * Gastric stimulator implant, * Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gastroparesis idiopathic gastroparesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroparesis

Contacts and locations

Locations

  • Dr Falk Investigational Site

    Chula Vista, California, 91910, United States

  • Dr Falk Investigational Site

    Lomita, California, 90717, United States

  • Dr Falk Investigational Site

    Clearwater, Florida, 33756, United States

  • Dr Falk Investigational Site

    Doral, Florida, 33126, United States

  • Dr Falk Investigational Site

    Hollywood, Florida, 33021, United States

  • Dr Falk Investigational Site

    Maitland, Florida, 32751, United States

  • Dr Falk Investigational Site

    Miami, Florida, 33144, United States

  • Dr Falk Investigational Site

    Miami, Florida, 33183, United States

  • Dr Falk Investigational Site

    Viera, Florida, 32940, United States

  • Dr Falk Investigational Site

    Topeka, Kansas, 66606, United States

  • Dr Falk Investigational Site

    Crestview Hills, Kentucky, 41017, United States

  • Dr Falk Investigational Site

    Houma, Louisiana, 70363, United States

  • Dr Falk Investigational Site

    Marrero, Louisiana, 70072, United States

  • Dr Falk Investigational Site

    Flint, Michigan, 48439, United States

  • Dr Falk Investigational Site

    Flint, Michigan, 48503, United States

  • Dr Falk Investigational Site

    New York, New York, 10033, United States

  • Dr Falk Investigational Site

    Tulsa, Oklahoma, 74104, United States

  • Dr Falk Investigational Site

    Philadelphia, Pennsylvania, 19087, United States

  • Dr Falk Investigational Site

    Cordova, Tennessee, 38018, United States

  • Dr Falk Investigational Site

    Nashville, Tennessee, 37211, United States

  • Dr Falk Investigational Site

    Harlingen, Texas, 78550, United States

  • University of Leuven

    Leuven, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.