Different Doses of Naronapride vs. Placebo in Gastroparesis
MOVE-IT
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
1 other identifier
interventional
328
2 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2023
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedStudy Start
First participant enrolled
January 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2025
CompletedApril 15, 2026
April 1, 2026
2.6 years
November 3, 2022
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12
12 weeks
Study Arms (4)
Naronapride 10 mg
EXPERIMENTALNaronapride 20 mg
EXPERIMENTALNaronapride 40 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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,
- 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),
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 18, 2022
Study Start
January 3, 2023
Primary Completion
August 12, 2025
Study Completion
September 4, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04