| Primary | 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. | The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed. | Posted | | Mean | Standard Deviation | Minutes | | Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablet by mouth once daily in the morning plus matching placebo in the evening for 14 days (+/-2 days) | | OG003 | Cohort 2- Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo | | OG004 | Cohort 3- 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG005 | Cohort 3- Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo |
| | Units | Counts |
|---|
| Participants | - OG00030
- OG00111
- OG00211
- OG003
|
| | Title | Denominators | Categories |
|---|
| T 1/2 Baseline | - ParticipantsOG00030
- ParticipantsOG00111
- ParticipantsOG00211
- ParticipantsOG003
|
| |
| Primary | 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. | The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed. | Posted | | Mean | Standard Deviation | Percent change in GE time | | Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | |
|
| Secondary | 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. | The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed. | Posted | | Mean | Standard Deviation | kPCD min-1 | | Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo | | OG002 | Cohort 2- 20 mg QD | CIN-102 20 mg tablets by mouth once daily in the morning and placebo tablets in the evening for 14 days (+/- 2 days) |
|
| Secondary | 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. | The Intent-to-Treat (ITT) Population included all randomized subjects. The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed. | Posted | | Mean | Standard Deviation | Percent change in GEBT excretion rate | | Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo | | OG002 | Cohort 2- 20 mg QD | CIN-102 20 mg tablets by mouth once daily in the morning and placebo tablets in the evening for 14 days (+/- 2 days) |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth once daily in the morning and placebo tablets in the evening for 14 days (+/- 2 days) |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo | | OG002 | Cohort 2- 20 mg QD | |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg QD tablets by mouth once daily in the morning and placebo tablets in the evening for 14 days (+/- 2 days) |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth once daily in the morning and placebo tablets in the evening for 14 days (+/- 2 days) |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days (+/- 2 days) | | OG002 | Cohort 2 - 20 mg QD | |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth once daily for 14 days plus matching placebo once daily |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (mean score for the 3 days preceding randomization) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth once daily for 14 days plus matching placebo once daily |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | |
|
| Secondary | 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. | The Intent-to-Treat Population included all randomized subjects. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | |
|
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 (single dose) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Mean | Standard Deviation | ng/mL | | Day 14 (steady state) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Median | Full Range | h | | Day 14 (steady state) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Median | Full Range | h | | Day 1 (single dose) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1 (single dose), Time 0 to 12 hours | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Secondary | 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. | PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 14 (steady state) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) | | OG001 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG002 | Cohort 3 - 5 mg BID | CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) |
| |
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
|
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
|
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
|
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
|
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
|
| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | The Safety Population included all randomized subjects who received study drug. | Posted | | Mean | Standard Deviation | Percent change in score | | Baseline (last available assessment prior to the first dose of study drug) to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) |
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| Other Pre-specified | 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. | Subjects from the Intent to Treat Population (all randomized subjects) with responses available. | Posted | | Count of Participants | | Participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 - 10 mg BID | CIN-102 10 mg tablets by mouth twice daily for 14 days | | OG001 | Cohort 1 - Placebo | Placebo tablets by mouth twice daily for 14 days | | OG002 | Cohort 2 - 20 mg QD | CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days) | | OG003 | Cohort 2- Placebo | |
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