Different Doses of Naronapride vs. Placebo in Gastroparesis

Gastroparesis Clinical Trial

— MOVE-IT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621811
• Other study ID #: NAT-19/GPX
• Status: Recruiting
• Phase: Phase 2
• Start date: January 3, 2023
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Naronapride
Naronapride is a 5HT-4 agonist
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	University of Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12		12 weeks