Trial Outcomes & Findings for Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial (NCT NCT01149369)

NCT ID: NCT01149369

Last Updated: 2019-05-08

Results Overview

The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 126 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-05-08

Participant Flow

Between April 2013 and July 2015, 126 patients were enrolled at eight participating medical centers, of whom 63 were randomized to aprepitant and 63 to placebo

Adults, 18 years or older, with symptoms compatible with gastroparesis for 6 months, who had a 4-hour gastric emptying scintigraphy test and a total score >21 on the Gastroparesis Cardinal Symptom Index (GCSI) and a visual analog scale (VAS) mean score of nausea after 7 days of >25 mm on a 0 to 100 mm scale were considered for enrollment.

Participant milestones

Measure	Aprepitant Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Overall Study STARTED	63	63
Overall Study COMPLETED	57	60
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	Aprepitant Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Overall Study Adverse Event	6	3

Baseline Characteristics

Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial

Baseline characteristics by cohort

Measure	Aprepitant n=63 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Total n=126 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 14.8 • n=5 Participants	46.8 years STANDARD_DEVIATION 13.5 • n=7 Participants	44.8 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White	53 participants n=5 Participants	59 participants n=7 Participants	112 participants n=5 Participants
Race/Ethnicity, Customized Black	8 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	63 participants n=7 Participants	126 participants n=5 Participants
Diabetes type 1 or type 2, No. Have diabetes type 1 or type 2	24 participants n=5 Participants	13 participants n=7 Participants	37 participants n=5 Participants
Diabetes type 1 or type 2, No. Do not have diabetes type 1 or type 2	39 participants n=5 Participants	50 participants n=7 Participants	89 participants n=5 Participants
Body mass index (BMI)	27.8 kg/m^2 STANDARD_DEVIATION 8.3 • n=5 Participants	28.0 kg/m^2 STANDARD_DEVIATION 7.5 • n=7 Participants	27.9 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants
Weight	75.4 kg STANDARD_DEVIATION 22.8 • n=5 Participants	75.1 kg STANDARD_DEVIATION 20.6 • n=7 Participants	75.2 kg STANDARD_DEVIATION 21.7 • n=5 Participants
Waist circumference	90.9 cm STANDARD_DEVIATION 17.2 • n=5 Participants	91.3 cm STANDARD_DEVIATION 18.0 • n=7 Participants	91.1 cm STANDARD_DEVIATION 17.5 • n=5 Participants
Waist to hip ratio	0.9 ratio STANDARD_DEVIATION 0.1 • n=5 Participants	0.9 ratio STANDARD_DEVIATION 0.1 • n=7 Participants	0.9 ratio STANDARD_DEVIATION 0.1 • n=5 Participants
Systolic blood pressure	121.1 mmHg STANDARD_DEVIATION 17.8 • n=5 Participants	122.1 mmHg STANDARD_DEVIATION 15.0 • n=7 Participants	121.6 mmHg STANDARD_DEVIATION 16.4 • n=5 Participants
Diastolic blood pressure	73.6 mmHg STANDARD_DEVIATION 11.6 • n=5 Participants	75.0 mmHg STANDARD_DEVIATION 11.3 • n=7 Participants	74.3 mmHg STANDARD_DEVIATION 11.4 • n=5 Participants
Medications in past month: proton pump inhibitors Took medication	42 participants n=5 Participants	51 participants n=7 Participants	93 participants n=5 Participants
Medications in past month: proton pump inhibitors Did not take medication	21 participants n=5 Participants	12 participants n=7 Participants	33 participants n=5 Participants
Medications in past month: benzodiazepine or anxiolytic Took medication	13 participants n=5 Participants	27 participants n=7 Participants	40 participants n=5 Participants
Medications in past month: benzodiazepine or anxiolytic Did not take medication	50 participants n=5 Participants	36 participants n=7 Participants	86 participants n=5 Participants
Medications in past month: prokinetic Took medication	25 participants n=5 Participants	18 participants n=7 Participants	43 participants n=5 Participants
Medications in past month: prokinetic Did not take medication	38 participants n=5 Participants	45 participants n=7 Participants	83 participants n=5 Participants
Medications in past month: antiemetic Took medication	44 participants n=5 Participants	49 participants n=7 Participants	93 participants n=5 Participants
Medications in past month: antiemetic Did not take medication	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants
Medications in past month: selective serotonin reuptake inhibitors (SSRI) Took medication	9 participants n=5 Participants	18 participants n=7 Participants	27 participants n=5 Participants
Medications in past month: selective serotonin reuptake inhibitors (SSRI) Did not take medication	54 participants n=5 Participants	45 participants n=7 Participants	99 participants n=5 Participants
Medications in past month: tricyclic antidepressant (TCA) Took medication	11 participants n=5 Participants	16 participants n=7 Participants	27 participants n=5 Participants
Medications in past month: tricyclic antidepressant (TCA) Did not take medication	52 participants n=5 Participants	47 participants n=7 Participants	99 participants n=5 Participants
Medications in past month: other antidepressant Took medication	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Medications in past month: other antidepressant Did not take medication	51 participants n=5 Participants	53 participants n=7 Participants	104 participants n=5 Participants
Medications in past month: narcotic Took medication	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Medications in past month: narcotic Did not take medication	57 participants n=5 Participants	59 participants n=7 Participants	116 participants n=5 Participants
Medications in past month: neuropathic or pain modulator... Took medication	27 participants n=5 Participants	29 participants n=7 Participants	56 participants n=5 Participants
Medications in past month: neuropathic or pain modulator... Did not take medication	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants
7-day nausea visual analog scale (VAS) score	63.0 units on a scale STANDARD_DEVIATION 21.5 • n=5 Participants	64.1 units on a scale STANDARD_DEVIATION 20.2 • n=7 Participants	63.6 units on a scale STANDARD_DEVIATION 20.8 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea	9.0 hours of nausea STANDARD_DEVIATION 7.0 • n=5 Participants	9.3 hours of nausea STANDARD_DEVIATION 7.1 • n=7 Participants	9.2 hours of nausea STANDARD_DEVIATION 7.1 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score	2.2 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	2.3 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	2.3 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity	2.6 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	2.6 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting severity	1.0 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	0.9 units on a scale STANDARD_DEVIATION 1.0 • n=7 Participants	1.0 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early satiety severity	2.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	2.7 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	2.6 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive fullness severity	2.7 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	2.7 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating severity	2.2 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	2.4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper abdominal pain severity	2.3 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	2.3 units on a scale STANDARD_DEVIATION 1.0 • n=7 Participants	2.3 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. episodes)	1.3 number of episodes STANDARD_DEVIATION 1.6 • n=5 Participants	1.1 number of episodes STANDARD_DEVIATION 1.5 • n=7 Participants	1.2 number of episodes STANDARD_DEVIATION 1.5 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. episodes)	2.0 number of episodes STANDARD_DEVIATION 2.5 • n=5 Participants	2.3 number of episodes STANDARD_DEVIATION 2.8 • n=7 Participants	2.1 number of episodes STANDARD_DEVIATION 2.6 • n=5 Participants
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall symptom severity	2.5 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	2.6 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI), total score	3.4 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	3.3 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
PAGI-SYM Severity index: Nausea/vomiting severity subscore	3.3 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	3.0 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
PAGI-SYM Severity index: Nausea severity	4.2 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	4.0 units on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	4.1 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
PAGI-SYM Severity index: Retching severity	3.0 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	2.8 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
PAGI-SYM Severity index: Vomiting severity	2.6 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants	1.9 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	2.2 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
PAGI-SYM Severity index: Fullness/early satiety subscore	3.7 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	3.7 units on a scale STANDARD_DEVIATION 0.8 • n=7 Participants	3.7 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
PAGI-SYM Severity index: Bloating subscore	3.3 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
PAGI-SYM Severity index: Upper abdominal pain subscore	3.4 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	3.3 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants
PAGI-SYM Severity index: Lower abdominal pain	2.4 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.5 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	2.5 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
PAGI-SYM Severity index: Lower abdominal discomfort	2.5 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	2.6 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) subscore	2.4 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	2.3 units on a scale STANDARD_DEVIATION 1.4 • n=7 Participants	2.3 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
PAGI-SYM Severity index: Constipation severity	2.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	2.8 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
PAGI-SYM Severity index: Diarrhea severity	1.6 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	1.7 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No. Nausea/vomiting predominant symptom	38 participants n=5 Participants	39 participants n=7 Participants	77 participants n=5 Participants
PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No. Nausea/vomiting not predominant symptom	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Clinical Global Patient Impression Score (patient-rated)	-0.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	-0.7 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	-0.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Brief Pain Inventory: severity score	4.7 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	4.6 units on a scale STANDARD_DEVIATION 2.5 • n=7 Participants	4.6 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Brief Pain Inventory: Interference score	4.4 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	5.4 units on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	4.9 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants
Beck Depression Inventory (BDI): Total score	18.0 units on a scale STANDARD_DEVIATION 11.8 • n=5 Participants	18.3 units on a scale STANDARD_DEVIATION 12.6 • n=7 Participants	18.2 units on a scale STANDARD_DEVIATION 12.1 • n=5 Participants
Beck Depression Inventory (BDI): Severe depression, No. Have severe depression	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Beck Depression Inventory (BDI): Severe depression, No. Do not have severe depression	52 participants n=5 Participants	53 participants n=7 Participants	105 participants n=5 Participants
State-Trait Anxiety Inventory (STAI): State anxiety score	39.6 units on a scale STANDARD_DEVIATION 13.9 • n=5 Participants	41.9 units on a scale STANDARD_DEVIATION 13.9 • n=7 Participants	40.7 units on a scale STANDARD_DEVIATION 13.9 • n=5 Participants
State-Trait Anxiety Inventory (STAI): Severe state anxiety, No. Have severe state anxiety	15 participants n=5 Participants	19 participants n=7 Participants	34 participants n=5 Participants
State-Trait Anxiety Inventory (STAI): Severe state anxiety, No. Do not have severe state anxiety	48 participants n=5 Participants	44 participants n=7 Participants	92 participants n=5 Participants
State-Trait Anxiety Inventory (STAI): Trait anxiety score	40.3 units on a scale STANDARD_DEVIATION 14.2 • n=5 Participants	43.0 units on a scale STANDARD_DEVIATION 13.2 • n=7 Participants	41.6 units on a scale STANDARD_DEVIATION 13.7 • n=5 Participants
State-Trait Anxiety Inventory: Severe trait anxiety, No. Have severe trait anxiety	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants
State-Trait Anxiety Inventory: Severe trait anxiety, No. Do not have severe trait anxiety	46 participants n=5 Participants	44 participants n=7 Participants	90 participants n=5 Participants
SF-36 Quality of Life (QOL): Physical component summary score	33.5 units on a scale STANDARD_DEVIATION 9.5 • n=5 Participants	29.8 units on a scale STANDARD_DEVIATION 8.8 • n=7 Participants	31.6 units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants
SF-36 Quality of Life (QOL): Mental component summary score	41.4 units on a scale STANDARD_DEVIATION 14.3 • n=5 Participants	40.5 units on a scale STANDARD_DEVIATION 13.5 • n=7 Participants	40.9 units on a scale STANDARD_DEVIATION 13.9 • n=5 Participants
Scintigraphic gastric emptying (GES): Percent gastric retention at 1 hour	69.7 percent retention STANDARD_DEVIATION 20.0 • n=5 Participants	73.0 percent retention STANDARD_DEVIATION 19.3 • n=7 Participants	71.3 percent retention STANDARD_DEVIATION 19.6 • n=5 Participants
Scintigraphic gastric emptying (GES): Percent gastric retention at 2 hours	45.6 percent retention STANDARD_DEVIATION 24.9 • n=5 Participants	53.1 percent retention STANDARD_DEVIATION 23.4 • n=7 Participants	49.4 percent retention STANDARD_DEVIATION 24.4 • n=5 Participants
Scintigraphic gastric emptying (GES): Percent gastric retention at 4 hours	17.8 percent retention STANDARD_DEVIATION 21.8 • n=5 Participants	20.4 percent retention STANDARD_DEVIATION 17.5 • n=7 Participants	19.1 percent retention STANDARD_DEVIATION 19.7 • n=5 Participants
Scintigraphic gastric emptying (GES): Delayed gastric emptying, No. Have delayed gastric emptying	29 participants n=5 Participants	43 participants n=7 Participants	72 participants n=5 Participants
Scintigraphic gastric emptying (GES): Delayed gastric emptying, No. Do not have delayed gastric emptying	34 participants n=5 Participants	20 participants n=7 Participants	54 participants n=5 Participants
Scintigraphic gastric emptying (GES): Rapid gastric emptying, No. Have rapid gastric emptying	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Scintigraphic gastric emptying (GES): Rapid gastric emptying, No. Do not have rapid gastric emptying	59 participants n=5 Participants	61 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.

Outcome measures

Measure	Aprepitant n=63 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Number of Participants With Improvement in Nausea	29 participants	25 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)	-2.5 hours of nausea Standard Deviation 3.2	-1.2 hours of nausea Standard Deviation 4.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)	-0.5 number of episodes Standard Deviation 1.0	-0.4 number of episodes Standard Deviation 1.1

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)	-0.5 number of episodes Standard Deviation 1.5	-0.7 number of episodes Standard Deviation 2.0

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score	-0.5 units on a scale Standard Deviation 0.9	-0.4 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity	-0.8 units on a scale Standard Deviation 1.0	-0.5 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity	-0.4 units on a scale Standard Deviation 0.8	-0.2 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity	-0.7 units on a scale Standard Deviation 0.9	-0.3 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity	-0.6 units on a scale Standard Deviation 0.9	-0.4 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity	0.1 units on a scale Standard Deviation 0.2	0.08 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity	-0.6 units on a scale Standard Deviation 1.0	-0.4 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity	-0.7 units on a scale Standard Deviation 0.8	-0.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Clinical Global Patient Impression Score (Patient-rated)	1.3 units on a scale Standard Deviation 1.4	1.0 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in serum alanine aminotransferase (ALT), U/L

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)	2.3 U/L Standard Deviation 36.6	0.8 U/L Standard Deviation 7.6

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in aspartate aminotransferase (AST), U/L

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)	3.1 U/L Standard Deviation 30.2	0.9 U/L Standard Deviation 7.7

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in total protein (g/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Liver Enzymes and Proteins: Total Protein	0.0 g/dL Standard Deviation 0.4	-0.1 g/dL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in hemoglobin A1c (HbA1c) (%)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Hemoglobin A1c (HbA1c)	-0.1 percent glycosylated hemoglobin Standard Deviation 1.0	0.1 percent glycosylated hemoglobin Standard Deviation 0.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in glucose (mg/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Glucose	9.6 mg/dL Standard Deviation 66.8	7.0 mg/dL Standard Deviation 44.8

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in albumin (g/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Liver Enzymes and Proteins: Albumin	-0.1 g/dL Standard Deviation 0.4	-0.1 g/dL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in hemoglobin (g/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Hemoglobin	-0.1 g/dL Standard Deviation 0.9	-0.2 g/dL Standard Deviation 0.6

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in hematocrit

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Hematocrit	-0.4 percentage RBCs Standard Deviation 2.7	-0.4 percentage RBCs Standard Deviation 1.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in white blood cell count (WBC)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
White Blood Cell Count (WBC)	-0.3 x10^9 cells/L Standard Deviation 1.5	-0.3 x10^9 cells/L Standard Deviation 1.8

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in red blood cell count (RBC)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Red Blood Cell Count (RBC)	-0.1 x10^6 cells/microliter Standard Deviation 0.3	-0.1 x10^6 cells/microliter Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in platelet count

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Platelet Count	-7.3 x10^3 cells/microliter Standard Deviation 47.1	4.8 x10^3 cells/microliter Standard Deviation 38.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in carbon dioxide (mEg/L)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Carbon Dioxide	-0.4 mEq/L Standard Deviation 2.5	0.4 mEq/L Standard Deviation 2.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in chloride (mEq/L)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Chloride	0.6 mEq/L Standard Deviation 3.0	-0.2 mEq/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in sodium (mEq/L)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Sodium	-0.3 mEq/L Standard Deviation 2.3	-0.7 mEq/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in potassium (mEq/L)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Potassium	0.1 mEq/L Standard Deviation 0.5	0.0 mEq/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in calcium (mg/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Calcium	-0.1 mg/dL Standard Deviation 0.4	-0.1 mg/dL Standard Deviation 0.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in blood urea nitrogen (BUN) (mg/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Blood Urea Nitrogen (BUN)	-0.9 mg/dL Standard Deviation 4.6	-0.3 mg/dL Standard Deviation 3.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in magnesium (mg/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Magnesium	0.0 mg/dL Standard Deviation 0.2	-0.0 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Change from baseline in creatinine (mg/dL)

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Creatinine	-0.1 mg/dL Standard Deviation 0.2	0.0 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score	-1.3 units on a scale Standard Deviation 1.0	-0.7 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore	-1.7 units on a scale Standard Deviation 1.3	-0.7 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Fullness/Early Satiety Subscore	-1.0 units on a scale Standard Deviation 1.3	-0.7 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Bloating Subscore	-1.2 units on a scale Standard Deviation 1.2	-0.6 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Upper Abdominal Pain Subscore	-1.1 units on a scale Standard Deviation 1.5	-0.6 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: GERD Subscore	-1.1 units on a scale Standard Deviation 1.3	-0.6 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Nausea Severity	-1.8 units on a scale Standard Deviation 1.5	-1.0 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Vomiting Severity	-1.6 units on a scale Standard Deviation 1.7	-0.5 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=59 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Retching Severity	-1.7 units on a scale Standard Deviation 1.6	-0.8 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Stomach Fullness Severity	-1.1 units on a scale Standard Deviation 1.6	-0.5 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Unable to Finish Meal Severity	-0.8 units on a scale Standard Deviation 1.4	-0.6 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Excessive Fullness Severity	-1.1 units on a scale Standard Deviation 1.4	-0.6 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Loss of Appetite Severity	-0.9 units on a scale Standard Deviation 1.6	-0.9 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Bloating Severity	-1.2 units on a scale Standard Deviation 1.4	-0.5 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Stomach Distention Severity	-1.1 units on a scale Standard Deviation 1.3	-0.7 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Upper Abdominal Pain Severity	-1.0 units on a scale Standard Deviation 1.6	-0.5 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity	-1.2 units on a scale Standard Deviation 1.6	-0.7 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Lower Abdominal Pain Severity	-0.8 units on a scale Standard Deviation 1.4	-0.6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity	-1.1 units on a scale Standard Deviation 1.4	-0.6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Heartburn During the Day Severity	-1.2 units on a scale Standard Deviation 1.5	-0.6 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Heartburn When Lying Down Severity	-1.2 units on a scale Standard Deviation 1.5	-0.7 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Chest Discomfort During the Day Severity	-1.1 units on a scale Standard Deviation 1.5	-0.7 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity	-0.9 units on a scale Standard Deviation 1.5	-0.6 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Regurgitation During the Day Severity	-1.2 units on a scale Standard Deviation 1.7	-0.5 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Regurgitation When Lying Down Severity	-1.3 units on a scale Standard Deviation 1.7	-0.5 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity: Bitter Taste Severity	-0.8 units on a scale Standard Deviation 1.6	-0.5 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Constipation Severity	-0.8 units on a scale Standard Deviation 1.6	-0.3 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
PAGI-SYM Severity Index: Diarrhea Severity	-0.1 units on a scale Standard Deviation 1.4	-0.2 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Total Score	-0.8 units on a scale Standard Deviation 0.9	-0.5 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score	-1.1 units on a scale Standard Deviation 1.5	-0.7 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 4 week

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score	-1.3 units on a scale Standard Deviation 1.1	-0.7 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 4 weeks

Population: The small number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score	-0.7 units on a scale Standard Deviation 1.3	-0.7 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score	-0.5 units on a scale Standard Deviation 1.6	0.1 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score	-0.8 units on a scale Standard Deviation 1.3	-0.4 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Brief Pain Inventory: Severity Score	-1.0 units on a scale Standard Deviation 2.6	-0.7 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Brief Pain Inventory: Interference Score	-1.1 units on a scale Standard Deviation 2.6	-1.0 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Beck Depression Inventory (BDI) Score	-4.6 units on a scale Standard Deviation 8.5	-2.4 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
State-Trait Anxiety Inventory (STAI): State Anxiety Score	-3.1 units on a scale Standard Deviation 8.7	-1.7 units on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	Aprepitant n=56 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=61 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
State-Trait Anxiety Inventory (STAI): Trait Anxiety Score	-1.8 units on a scale Standard Deviation 8.8	-0.7 units on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Satiety Test, Volume Consumed	-13.0 mL Interval -75.85 to 49.85	9.2 mL Interval -56.35 to 74.75

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement	-4.6 average power in frequency region, % Standard Deviation 24.6	2.8 average power in frequency region, % Standard Deviation 21.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is <2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement	2.1 average power in frequency region, % Standard Deviation 17.7	0.5 average power in frequency region, % Standard Deviation 19.4

SECONDARY outcome

Timeframe: 4 weeks

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement	1.0 average power in frequency region, % Standard Deviation 19.9	-1.0 average power in frequency region, % Standard Deviation 16.5

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement	1.0 average power in frequency region, % Standard Deviation 15.8	0.8 average power in frequency region, % Standard Deviation 15.1

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement	1.5 average power in frequency region, % Standard Deviation 12.3	-1.6 average power in frequency region, % Standard Deviation 12.0

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement	-2.1 average power in frequency region, % Standard Deviation 9.7	-0.8 average power in frequency region, % Standard Deviation 14.1

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week followup visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement	2.1 average power in frequency region, % Standard Deviation 13.5	-0.2 average power in frequency region, % Standard Deviation 13.4

SECONDARY outcome

Timeframe: 4 weeks

Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.

Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is >10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).

Outcome measures

Measure	Aprepitant n=48 Participants Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=55 Participants Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement	-0.8 average power in frequency region, % Standard Deviation 7.3	-0.5 average power in frequency region, % Standard Deviation 5.5

Adverse Events

Aprepitant

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Aprepitant-placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aprepitant n=63 participants at risk Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 participants at risk Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Endocrine disorders Hypoglycemia	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks

Other adverse events

Measure	Aprepitant n=63 participants at risk Aprepitant 125 mg per day Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks	Aprepitant-placebo n=63 participants at risk Placebo aprepitant 125mg per day Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Gastrointestinal disorders Nausea, vomiting	1.6% 1/63 • Number of events 1 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Gastrointestinal disorders Nausea	1.6% 1/63 • Number of events 1 • 4 weeks	3.2% 2/63 • Number of events 2 • 4 weeks
Gastrointestinal disorders Vomiting	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Eye disorders Flashing lights/floaters	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Skin and subcutaneous tissue disorders Bruising	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
General disorders Fatigue	3.2% 2/63 • Number of events 2 • 4 weeks	3.2% 2/63 • Number of events 2 • 4 weeks
Gastrointestinal disorders Gastrointestinal - Other (abdominal pain)	4.8% 3/63 • Number of events 3 • 4 weeks	3.2% 2/63 • Number of events 2 • 4 weeks
Gastrointestinal disorders Diarrhea	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Gastrointestinal disorders Nausea, abdominal pain, diarrhea	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Metabolism and nutrition disorders Hypokalemia	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
General disorders Diarrhea, syncope	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal - Other (neck and right hand pain)	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Gastrointestinal disorders Diarrhea, loss of appetite	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Gastrointestinal disorders Gastrointestinal - Other (fainting sensation)	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Renal and urinary disorders Renal/Genitourinary - Other (Bleeding)	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Renal and urinary disorders Fibromyalgia cystitis	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Nervous system disorders Dizziness	3.2% 2/63 • Number of events 2 • 4 weeks	0.00% 0/63 • 4 weeks
Gastrointestinal disorders Constipation	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Immune system disorders Rhinitis	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Nervous system disorders Headache	3.2% 2/63 • Number of events 2 • 4 weeks	0.00% 0/63 • 4 weeks
Gastrointestinal disorders Gastrointestinal - Other (Nausea, malaise)	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal - Other (Limb pain)	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Blood and lymphatic system disorders Nosebleed	1.6% 1/63 • Number of events 1 • 4 weeks	0.00% 0/63 • 4 weeks
Blood and lymphatic system disorders Bruising	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Psychiatric disorders Depression	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks
Nervous system disorders Neurology - other	0.00% 0/63 • 4 weeks	1.6% 1/63 • Number of events 1 • 4 weeks

Additional Information

Katherine Yates

Johns Hopkins Data Coordinating Center

Phone: 443-287-0082

Email: kyates1@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place