RECRUITING

Different Doses of Naronapride vs. Placebo in Gastroparesis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-01-03
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05621811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women between ≥18 and ≤75 years of age,
  2. * Body Mass Index (BMI) ≥16 and \<35 kg/m2 ,
  3. * History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months,
  4. * 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,
  5. * 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,
  6. * 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,
  7. * 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),
  8. * 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),
  1. * History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy,
  2. * Intrapyloric botulinum toxin injection within 12 months,
  3. * Gastric stimulator implant,
  4. * Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,

Contacts and Locations

Study Locations (Sites)

Dr Falk Investigational Site
Lomita, California, 90717
United States
Dr Falk Investigational Site
Clearwater, Florida, 33756
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
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
Harlingen, Texas, 78550
United States

Collaborators and Investigators

Sponsor: Dr. Falk Pharma GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-03
Study Completion Date2025-04

Study Record Updates

Study Start Date2023-01-03
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • stomach
  • diabetes mellitus

Additional Relevant MeSH Terms

  • Gastroparesis