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NCT05621811RECRUITINGIRB Ready

Different Doses of Naronapride Vs. Placebo in Gastroparesis

(MOVE-IT)

Sponsored by Dr. Falk Pharma GmbH

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Men and women between โ‰ฅ18 and โ‰ค75 years of age,
Body Mass Index (BMI) โ‰ฅ16 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 โ‰ฅ3 months,
Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 โ‰ฅ 85.33 minutes (โ‰ฅ 90th percentile of normative data) during the screening phase,
Average weekly total symptom score of the ANMS GCSI-DD โ‰ฅ2.0 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 โ‰ค11% under stable antidiabetic medication, *

Exclusion Criteria

of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy dur

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

320 participants

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Age Range

18 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Dr. Falk Pharma GmbH

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Chula Vista

California

Location available
View Chula Vista location page
RECRUITING

Lomita

California

Location available
View Lomita location page
RECRUITING

Clearwater

Florida

Location available
View Clearwater location page
RECRUITING

Doral

Florida

Location available
View Doral location page
RECRUITING

Hollywood

Florida

Location available
View Hollywood location page
RECRUITING

Maitland

Florida

Location available
View Maitland location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Viera

Florida

Location available
View Viera location page

๐Ÿ“ And 12 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Gastroparesis Treatment in Chula Vista?

Join others in California exploring innovative treatment options through clinical research

Gastroparesis Treatment Options in Chula Vista, California

If you're searching for Gastroparesis treatment in Chula Vista, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chula Vista, Lomita, Clearwater and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Gastroparesis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 320 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Gastroparesis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Gastroparesis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Gastroparesis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05621811. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.