Clinical trial NCT05621811: Different Doses of Naronapride Vs. Placebo in Gastroparesis
Official title: Double-blind, Randomised, Placebo-controlled, Dose-finding Phase IIb Trial to Evaluate the Efficacy, Safety, and Tolerability of a 12-week-treatment with Naronapride in Adult Participants with At Least Moderate Idiopathic or Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastroparesis
Keywords: stomach
diabetes mellitus
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Dr Falk Investigational Site
state: California
city: Lomita
country: United States
facility: Dr Falk Investigational Site
state: California
city: Clearwater
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Doral
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Maitland
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Miami
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Miami
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Viera
country: United States
facility: Dr Falk Investigational Site
state: Florida
city: Topeka
country: United States
facility: Dr Falk Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Dr Falk Investigational Site
state: Kentucky
city: Houma
country: United States
facility: Dr Falk Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Dr Falk Investigational Site
state: Louisiana
city: Flint
country: United States
facility: Dr Falk Investigational Site
state: Michigan
city: Flint
country: United States
facility: Dr Falk Investigational Site
state: Michigan
city: New York City
country: United States
facility: Dr Falk Investigational Site
state: New York
city: Tulsa
country: United States
facility: Dr Falk Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Dr Falk Investigational Site
state: Pennsylvania
city: Cordova
country: United States
facility: Dr Falk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Dr Falk Investigational Site
state: Tennessee
city: Harlingen
country: United States
facility: Dr Falk Investigational Site
state: Texas
city: Leuven
country: Belgium
facility: University of Leuven
Study officials:
References: