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5-HT4 Receptor Agonist

Naronapride for Gastroparesis (MOVE-IT Trial)

Phase 2
Recruiting
Research Sponsored by Dr. Falk Pharma GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months
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
Must not have
History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, colectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will test different doses of a drug called Naronapride compared to a placebo to see which one is more effective for treating patients with Gastroparesis. The trial will be conducted at

Who is the study for?
Adults aged 18-75 with gastroparesis, confirmed by a breath test showing delayed gastric emptying. They must have had symptoms like nausea or bloating for at least 3 months and have a BMI between 16 and 35. People with diabetes can join if their condition is stable (HbA1c ≤11%). Those with any mechanical blockages in the stomach or previous surgeries that could affect results are not eligible.
What is being tested?
This study tests different doses of Naronapride (10, 20, or 40 mg) against a placebo to see which works best for gastroparesis. Participants will be randomly assigned to one of these four groups without knowing which one they're in—a process known as double-blind.
What are the potential side effects?
Possible side effects of Naronapride may include abdominal pain, changes in bowel movements, headache, fatigue, and potential allergic reactions. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had symptoms of gastroparesis for 3 months or more.
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My average weekly symptom score is 2.0 or higher.
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My diabetes is under control with medication, and my HbA1c is 11% or lower.
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My scans show no signs of narrow intestines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had major surgery on my digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Naronapride 40 mgExperimental Treatment1 Intervention
Group II: Naronapride 20 mgExperimental Treatment1 Intervention
Group III: Naronapride 10 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Dr. Falk Pharma GmbHLead Sponsor
44 Previous Clinical Trials
8,910 Total Patients Enrolled
~14 spots leftby Jan 2025
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