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A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

Description

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo * To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo Participants will go through the following schedule: * Pre-screening (1 visit) * Screening \& Lead-In (1-2 visits) * Will complete a Gastric Emptying Breath Test (GEBT) * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation. * Lead-In Period (1 visit) * 12-week treatment period (7 visits) * Study drug taken twice daily by mouth * Will complete daily diaries and other PROs as described in protocol * 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: * 15 mg CIN-102, taken orally BID for 12 weeks * 10 mg CIN-102, taken orally BID for 12 weeks * Placebo for CIN-102, taken orally BID for 12 weeks

Conditions

Idiopathic Gastroparesis
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Related Conditions:

Idiopathic Gastroparesis

Study Overview

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Study Details

Study overview

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo * To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo Participants will go through the following schedule: * Pre-screening (1 visit) * Screening \& Lead-In (1-2 visits) * Will complete a Gastric Emptying Breath Test (GEBT) * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation. * Lead-In Period (1 visit) * 12-week treatment period (7 visits) * Study drug taken twice daily by mouth * Will complete daily diaries and other PROs as described in protocol * 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: * 15 mg CIN-102, taken orally BID for 12 weeks * 10 mg CIN-102, taken orally BID for 12 weeks * Placebo for CIN-102, taken orally BID for 12 weeks

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

Condition
Idiopathic Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Foley

G & L Research, LLC, Foley, Alabama, United States, 36535

Saraland

The Center for Clinical Trials, Saraland, Alabama, United States, 36571

Tucson

Del Sol Research Management, LLC, Tucson, Arizona, United States, 85715

Little Rock

Applied Research Center of Arkansas, Inc, Little Rock, Arkansas, United States, 72205

Little Rock

Preferred Research Partners, Inc., Little Rock, Arkansas, United States, 72211

Canoga Park

Hope Clinical Research LLC, Canoga Park, California, United States, 91303

Chula Vista

Erick H. Alayo Medical Corporation, Chula Vista, California, United States, 91910

Covina

Flourish Research - Los Angeles (Covina), Covina, California, United States, 91723

Lancaster

Gastro Care Institute, Lancaster, California, United States, 93534

Los Angeles

Downtown L.A. Research Center, Inc., Los Angeles, California, United States, 90017

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Is a male or female ≥18 years of age;
  • * Has a current diagnosis of gastroparesis defined by the following:
  • 1. Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
  • 2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit 2.
  • * Body mass index between 17 and 45 kg/m2, inclusive;
  • * If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss, may be considered for the study if ALL of the following criteria are satisfied:
  • 1. Has been on a stable dose of GLP-1RA for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
  • 2. Is tolerating the GLP-1RA well, according to the Investigator's judgment;
  • 3. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the GLP-1RA;
  • 4. Symptoms of gastroparesis were present before starting GLP-1RA therapy; and
  • 5. Is not taking the GLP-1RA for the management of diabetes or blood glucose control.
  • * Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders \[eg, scleroderma, systemic lupus erythematosus\], or other neurologic disorder \[eg, Parkinson's disease\]);
  • * Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
  • * Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
  • * Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
  • * Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
  • * Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
  • * Has a history of gastric surgery;
  • * Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
  • * Has a history of severe and refractory constipation;
  • * Has a history or evidence of clinically significant arrhythmia;
  • * Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression;
  • * Has a substance use disorder or a positive alcohol or positive drug screen.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CinDome Pharma, Inc.,

Study Record Dates

2026-06-23