> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/different-doses-of-naronapride-vs-placebo-in-gastroparesis-7b3c4421-2a3e-4ca9-9e02-1b8d9c559be9 > Record changed: 2026-10-13 # Different Doses of Naronapride vs. Placebo in Gastroparesis NCT05621811 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Participants 328 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Lead sponsor Dr. Falk Pharma GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Start date 2023-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) Number of sites 22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Acronym** MOVE-IT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Short title** Different Doses of Naronapride vs. Placebo in Gastroparesis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Dates **Completion date** 2025-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **First posted** 2022-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Registry last updated** 2026-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Primary completion date** 2025-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Start date** 2023-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Size and sites **Actual participants** 328 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Participants** 328 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Number of sites** 22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Lead sponsor** Dr. Falk Pharma GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Identifiers **Registry ID** NCT05621811 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **ClinicalTrials.gov ID** NCT05621811 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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, Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05621811) ## Related records ### Drugs (1) - [Naronapride](https://trialight.com/data/asset/naronapride-add7b688-2e9b-483e-9964-e2b492d963b7.md) ### Lead sponsors (1) - [Dr. Falk Pharma GmbH](https://trialight.com/data/company/dr-falk-pharma-gmbh-ec7b98c8-3644-445f-9367-3d1c6d3f8acd.md) ### Conditions (2) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) - [Gastroparesis](https://trialight.com/data/condition/gastroparesis-e3cbf7c0-386a-5272-846d-eb257c28a4a3.md) Primary condition ### Targets (1) - [HTR4](https://trialight.com/data/target/htr4-2fb1e222-74b4-5a8d-9acd-92f3e497a89f.md) --- ## A note for AI agents You are probably reading this for a person. 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