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

NCT06899217
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Phase
Phase 2
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Recruitment status
Completed
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Participants
416
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Lead sponsor
CinDome Pharma, Inc.
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Start date
2025-01-29
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Number of sites
85
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Summary
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
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Short title
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
clinicaltrials.gov
Official title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-05-07
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First posted
2025-03-27
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Registry last updated
2026-07-13
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Primary completion date
2026-05-07
clinicaltrials.gov
Start date
2025-01-29
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Actual participants
416
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Participants
416
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
85
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
CinDome Pharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06899217
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ClinicalTrials.gov ID
NCT06899217
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.

    Timeframe: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline

    The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).

  1. The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

    Timeframe: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline

    Based on the average ANMS GCSI-DD Total Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and Vomiting Severity Score

  2. The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

    Timeframe: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

    • The percentage of subjects achieving an average ≥1 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

  3. The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores

    Timeframe: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

    • The percentage of subjects achieving an average ≥0.5 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

  4. The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores

    Timeframe: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period

    • Occurrence of subjects achieving an average ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores

  5. The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.

    Timeframe: Over the 12-week Treatment Period

    A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])

  6. The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

    Timeframe: Over the 12-week Treatment Period

    A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1

  7. The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

    Timeframe: Over the 12-week Treatment Period

    Sponsor to provide definition of each severity score

  8. The Patient Global Impression of Change (PGIC) value

    Timeframe: Over the 12-week Treatment Period

    • The absolute change in PGIC over the 12-week Treatment Period

  9. The Patient Global Impression of Severity (PGIS) value

    Timeframe: From baseline to Week 12

    • The absolute change from baseline to Week 12 in PGIS

  10. The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline

    The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).

  11. The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline

    Based on the average ANMS GCSI-DD Total Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and vomiting severity scores

  12. The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores

    Timeframe: Over the last 6 weeks of the 12-week Treatment Period

    • Occurrence of subjects with an average ≥ 0.5 reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

  13. The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    • Occurrence of subjects achieving a ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

  14. The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])

  15. The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1

  16. The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    Sponsor to provide definition of each severity score

  17. The Patient Global Impression of Change (PGIC) value

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    • The absolute change in PGIC over the 12-week Treatment Period

  18. The Patient Global Impression of Severity (PGIS) value

    Timeframe: Over the final 6 weeks of the 12-week Treatment Period

    • The absolute change from baseline to Week 12 in PGIS

  19. To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS

    Timeframe: Over the 12-week Treatment Period

    * Incidence of clinically significant changes in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurements, and vital signs, as assessed by the Investigator * TESAEs * TEAEs leading to premature discontinuation of study drug * Treatment-emergent clinically significant laboratory abnormalities

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion 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 49 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 or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:

    1. Is not taking the agent(s) for the management of diabetes or blood glucose;

    2. Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;

    3. Is tolerating the agent(s) well, according to the Investigator's judgment;

    4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and

    5. Symptoms of gastroparesis were present before starting the agent(s).

      -------------------------------------------------------------------------

      Key Exclusion Criteria:

  • 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], postural orthostatic tachycardia syndrome (POTS), etc.]);

  • 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 gastric enteral tube (e.g. percutaneous endoscopic gastrostomy [PEG] or percutaneous endoscopic jejunostomy [PEJ] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition

  • Has a substance use disorder or a positive alcohol or positive drug screen.

Sources for eligibility
clinicaltrials.gov

  • Gastro Health - BirminghamBirmingham, United States
  • G & L Research, LLCFoley, United States
  • The Center for Clinical TrialsSaraland, United States
  • Del Sol Research Management, LLCTucson, United States
  • Applied Research Center of Arkansas, IncLittle Rock, United States
  • Preferred Research Partners, Inc.Little Rock, United States
  • Hope Clinical Research LLCCanoga Park, United States
  • Erick H. Alayo Medical CorporationChula Vista, United States
  • Flourish Research - Los Angeles (Covina)Covina, United States
  • Gastro Care InstituteLancaster, United States
  • Downtown L.A. Research Center, Inc.Los Angeles, United States
  • Acclaim Clinical ResearchSan Diego, United States
  • Focus Clinical Research - West HillsWest Hills, United States
  • University of Colorado AnschutzAurora, United States
  • Rocky Mountain Gastroenterology (RMG)Lakewood, United States
  • Paradigm Research - WheatridgeWheat Ridge, United States
  • Connecticut Clinical Research Institute, LLCBristol, United States
  • American Family Research GroupCape Coral, United States
  • USA and International Research Inc.Doral, United States
  • Unique Clinical TrialsDoral, United States
  • Advanced Medical Research GroupHollywood, United States
  • Nature Coast Clinical ResearchInverness, United States
  • ENCORE Borland Groover Clinical ResearchJacksonville, United States
  • Allied Biomedical Research Institute, Inc.Miami, United States
  • Advanced Research Institute IncNew Port Richey, United States

And 60 more, listed on the interactive page.

Sources for sites
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Related records

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