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

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: Terminated
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: CIN-102 Dose 1; Drug: CIN-102 Dose 2; Drug: CIN-102 Dose 3

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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)	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

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in GE as Measured by the GEBT Excretion Rate	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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)	AUCtau is defined as the area under the plasma concentration-time curve over the dosing interval.	Day 14 (steady state)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in PAGI-SYM Total Score	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: CinDome Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis
• Other Study ID 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