Trial Outcomes & Findings for Sancuso® for Gastroparesis: An Open Label Study. (NCT NCT01989221)

Results Overview

The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

Three weeks

Results posted on

2021-05-26

Participant Flow

goal was 20 patients, 14 entered

Participant milestones

Participant milestones
Measure	Placebo Followed by Sancuso Placebo at baseline for one week followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours for two weeks
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Followed by Sancuso n=14 Participants Placebo - Control for 1 week followed by Sancuso® (3.1 mg/24 hours) for 2 weeks
Sex: Female, Male Female	13 Participants n=14 Participants
Sex: Female, Male Male	1 Participants n=14 Participants
Region of Enrollment United States	14 participants n=14 Participants
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants

PRIMARY outcome

Timeframe: Three weeks

The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.

Outcome measures

Outcome measures
Measure	Placebo Followed by Sancuso n=14 Participants Placebo - Control followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
GCSI-DD Total Composite Symptom Scores. Baseline	1.89 score on a scale Standard Deviation 0.15
GCSI-DD Total Composite Symptom Scores. Week 1 of Treatment	1.57 score on a scale Standard Deviation 0.20
GCSI-DD Total Composite Symptom Scores. Week 2 of Treatment	1.34 score on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: Three weeks

The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) was used to capture the severity of symptoms during one week at baseline and at two weeks of treatment with GTS. The GCSI-DD includes questions about severity of nausea, early satiety, postprandial fullness, upper abdominal pain, and overall symptoms. Patients rated their symptom severity on a scale of 0 (no symptom), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe) and recorded the number of vomiting episodes per day. A daily composite score was calculated as the average of the five symptom scores (not including overall symptom severity) with a cap of 4 vomiting episodes per day.

Outcome measures

Outcome measures
Measure	Placebo Followed by Sancuso n=14 Participants Placebo - Control followed by Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
Total Gastrointestinal Nausea and Vomiting Symptom Index Baseline	2.31 score on a scale Standard Deviation 0.17
Total Gastrointestinal Nausea and Vomiting Symptom Index Week 1 of Treatment	1.69 score on a scale Standard Deviation 0.28
Total Gastrointestinal Nausea and Vomiting Symptom Index Week 2 of Treatment	1.30 score on a scale Standard Deviation 0.27

Adverse Events

Sancuso

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sancuso n=14 participants at risk Sancuso (3.1mg/24 hours) for 2 weeks
Skin and subcutaneous tissue disorders Itching	14.3% 2/14 • Number of events 2 • 4 weeks
Skin and subcutaneous tissue disorders Redness at the patch site	7.1% 1/14 • Number of events 1 • 4 weeks
General disorders Headache	7.1% 1/14 • Number of events 1 • 4 weeks
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • 4 weeks
Product Issues Poor Patch Adherence	35.7% 5/14 • Number of events 5 • 4 weeks

Additional Information

Dr. Henry Parkman

TempleU

Phone: 2157072498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place