Different Doses of Naronapride vs. Placebo in Gastroparesis

NCT05621811
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Phase
Phase 2
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Recruitment status
Completed
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Participants
328
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Lead sponsor
Dr. Falk Pharma GmbH
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Start date
2023-01-03
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Number of sites
22
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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.
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Acronym
MOVE-IT
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Short title
Different Doses of Naronapride vs. Placebo in Gastroparesis
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-09-04
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First posted
2022-11-18
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Registry last updated
2026-04-15
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Primary completion date
2025-08-12
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Start date
2023-01-03
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Actual participants
328
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Participants
328
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
22
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Dr. Falk Pharma GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05621811
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ClinicalTrials.gov ID
NCT05621811
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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  1. Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary total score from baseline to week 12

    Timeframe: 12 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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),

  • 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,
Sources for eligibility
clinicaltrials.gov

  • Chula Vista, United States
  • Lomita, United States
  • Clearwater, United States
  • Doral, United States
  • Hollywood, United States
  • Maitland, United States
  • Miami, United States
  • Miami, United States
  • Viera, United States
  • Topeka, United States
  • Crestview Hills, United States
  • Houma, United States
  • Marrero, United States
  • Flint, United States
  • Flint, United States
  • New York, United States
  • Tulsa, United States
  • Philadelphia, United States
  • Cordova, United States
  • Nashville, United States
  • Harlingen, United States
  • University of LeuvenLeuven, Belgium
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)