Different Doses of Naronapride Vs. Placebo in Gastroparesis
NCT ID: NCT05621811
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2023-01-03
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naronapride 10 mg
Naronapride
Naronapride is a 5HT-4 agonist
Naronapride 20 mg
Naronapride
Naronapride is a 5HT-4 agonist
Naronapride 40 mg
Naronapride
Naronapride is a 5HT-4 agonist
Placebo
Placebo
Placebo
Interventions
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Naronapride
Naronapride is a 5HT-4 agonist
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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,
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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Dr Falk Investigational Site
Chula Vista, California, United States
Dr Falk Investigational Site
Lomita, California, United States
Dr Falk Investigational Site
Clearwater, Florida, United States
Dr Falk Investigational Site
Doral, Florida, United States
Dr Falk Investigational Site
Hollywood, Florida, United States
Dr Falk Investigational Site
Maitland, Florida, United States
Dr Falk Investigational Site
Miami, Florida, United States
Dr Falk Investigational Site
Miami, Florida, United States
Dr Falk Investigational Site
Viera, Florida, United States
Dr Falk Investigational Site
Topeka, Kansas, United States
Dr Falk Investigational Site
Crestview Hills, Kentucky, United States
Dr Falk Investigational Site
Houma, Louisiana, United States
Dr Falk Investigational Site
Marrero, Louisiana, United States
Dr Falk Investigational Site
Flint, Michigan, United States
Dr Falk Investigational Site
Flint, Michigan, United States
Dr Falk Investigational Site
New York, New York, United States
Dr Falk Investigational Site
Tulsa, Oklahoma, United States
Dr Falk Investigational Site
Philadelphia, Pennsylvania, United States
Dr Falk Investigational Site
Cordova, Tennessee, United States
Dr Falk Investigational Site
Nashville, Tennessee, United States
Dr Falk Investigational Site
Harlingen, Texas, United States
University of Leuven
Leuven, , Belgium
Countries
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Facility Contacts
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Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Dr Falk Investigational Site
Role: primary
Other Identifiers
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NAT-19/GPX
Identifier Type: -
Identifier Source: org_study_id
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