A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

March 5, 2026 updated by: CinDome Pharma, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Research Site 101
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site 114
      • Miami, Florida, United States, 33134
        • Research Site 117
      • Miami, Florida, United States, 33183
        • Research Site 118
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site 111
    • Kansas
      • Kansas City, Kansas, United States, 66045
        • Research Site 110
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site 103
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site 112
      • Monroe, Louisiana, United States, 71201
        • Research Site 104
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site 102
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Research Site 121
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Research Site 113
    • New York
      • Great Neck, New York, United States, 11023
        • Research Site 109
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site 120
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Research Site 105
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Research Site 106
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Research Site 119
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site 115
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site 107

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients 18 to 70 years old.
  • Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
  • Presence of moderate to severe nausea.
  • Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
  • Glycosylated hemoglobin level <11% at Screening.
  • Willing to washout from ongoing treatment for gastroparesis.
  • Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

  • Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
  • Positive test for drugs of abuse at the screening or evaluation visits.
  • Personal or family history of prolonged heart rate-corrected QT.
  • History or evidence of clinically significant arrhythmia.
  • History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
  • Females who are pregnant, nursing, or planning on becoming pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
CIN-102 tablets by mouth twice daily for 14 days
Drug: CIN-102 Dose 1
CIN-102 Dose 1
Placebo Comparator: Cohort 1 - Placebo
Placebo tablets by mouth twice daily for 14 days
Drug: Placebo
Placebo
Experimental: Cohort 2
CIN-102 tablets by mouth twice daily for 14 days
Drug: CIN-102 Dose 2
CIN-102 Dose 2
Placebo Comparator: Cohort 2- Placebo
Placebo tablets by mouth twice daily for 14 days
Drug: Placebo
Placebo
Experimental: Cohort 3
CIN-102 tablets by mouth twice daily for 14 days
Drug: CIN-102 Dose 3
CIN-102 Dose 3
Active Comparator: Cohort 3- Placebo
Placebo tablets by mouth twice daily for 14 days
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)
Time Frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE), after consumption of a standardized 13C-enriched meal. GEBT T1/2 is the time for half of the ingested meal to leave the stomach. It is reported using kPCD, a mathematical expression of a test subject's 13CO2 excretion rate per minute at any measurement time t relative to the dose of 13C contained in the test meal.
Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)
Time Frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE), after consumption of a standardized 13C-enriched meal. GEBT T1/2 is the time for half of the ingested meal to leave the stomach. It is reported using kPCD, a mathematical expression of a test subject's 13CO2 excretion rate per minute at any measurement time t relative to the dose of 13C contained in the test meal.
Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Change From Baseline in GE as Measured by the GEBT Excretion Rate
Time Frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The value and change from baseline in GEBT excretion rate (kPCD per minute) were summarized by treatment group. The value and time-matched (to baseline visit) change from baseline of the GEBT results for each post-meal time point were also summarized by treatment group.
Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate
Time Frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The percent change from baseline in GEBT excretion rate (kPCD per minute) was summarized by treatment group. The percent change from baseline of the GEBT results for each post-meal time point was also summarized by treatment group.
Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Change From Baseline in ANMS GCSI-DD Total Scores
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) total and subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Total Scores
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) total and subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
Time Frame: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 1
Time Frame: Day 1 (single dose)
CMAX is defined as the maximum observed drug concentration after administration.
Day 1 (single dose)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 14
Time Frame: Day 14 (steady state)
CMAX is defined as the maximum observed drug concentration after administration.
Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 14
Time Frame: Day 14 (steady state)
TMAX is defined as the time to maximum plasma concentration.
Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 1
Time Frame: Day 1 (single dose)
TMAX is defined as the time to maximum plasma concentration.
Day 1 (single dose)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Area Under the Plasma Concentration-time Curve From Pre-dose (Time 0) to 12 Hours (AUC0-12)
Time Frame: Day 1 (single dose), Time 0 to 12 hours
AUC0-12 is defined as the area under the plasma concentration-time curve from pre-dose (Time 0) to 12 Hours on Day 1 of CIN-102 dosing.
Day 1 (single dose), Time 0 to 12 hours
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau)
Time Frame: Day 14 (steady state)
AUCtau is defined as the area under the plasma concentration-time curve over the dosing interval.
Day 14 (steady state)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Change From Baseline in PAGI-SYM Total Score
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) total score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Total Score
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) total score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Score - Heartburn/Regurgitation
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Score - Heartburn/Regurgitation
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Score - Fullness/Early Satiety
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Score - Fullness/Early Satiety
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Score - Nausea/Vomiting
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Score - Nausea/Vomiting
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Score - Bloating
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Score - Bloating
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Scores - Upper Abdominal Pain
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Scores - Upper Abdominal Pain
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Change From Baseline in PAGI-SYM Subscale Score - Lower Abdominal Pain
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score and change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
The Percent Change From Baseline in PAGI-SYM Subscale Score - Lower Abdominal Pain
Time Frame: Baseline (last available assessment prior to the first dose of study drug) to Day 14
Patient Assessment of Gastrointestinal Symptom Severity Index (PAGI-SYM) subscale score percent change for the Safety Population. PAGI-SYM is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in upper gastrointestinal disorders. The PAGI-SYM assesses heartburn/regurgitation, post-prandial fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain calculated from a 6-point likert scale ranging from 0-5 with high scores reflecting greater symptom severity. The negative change from baseline indicates improvement.
Baseline (last available assessment prior to the first dose of study drug) to Day 14
Clinical Grading Assessment Scale at Day 14
Time Frame: Day 14
The Clinical Grading Assessment Scale is a patient and investigator reported outcome instrument for a clinical trial endpoint. Completed at Day 14, the assessment asks subjects about how their stomach/gastroparesis-related problems/symptoms compare to the period before they started treatment in the study based on a 15-point likert scale, where +7 is completely better, 0 is no change, and -7 is very much worse.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CinDome Pharma, Inc.

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIN-102-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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