Trial Outcomes & Findings for Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting (NCT NCT02457195)
NCT ID: NCT02457195
Last Updated: 2019-12-18
Results Overview
Composite measure consisting of complete response (CR), defined as no emetic episode and no rescue medication; the proportions of patients with no emesis and no additional rescue medication in the 120 hours following the completion of surgical procedure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
24 hrs, 48 hrs, 72 hrs and 120 hrs
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Admnistration of Granisetron
Preoperative administration of granisetron transdemal patch
granisetron: Application granisetron transdermal patch preoperatively
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Admnistration of Granisetron
Preoperative administration of granisetron transdemal patch
granisetron: Application granisetron transdermal patch preoperatively
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Admnistration of Granisetron
n=50 Participants
Preoperative administration of granisetron transdemal patch
granisetron: Application granisetron transdermal patch preoperatively
|
|---|---|
|
Age, Customized
18-21 years : female
|
0 participants
n=5 Participants
|
|
Age, Customized
18-21 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
22-29 years : female
|
2 participants
n=5 Participants
|
|
Age, Customized
22-29 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
30-39 years : female
|
5 participants
n=5 Participants
|
|
Age, Customized
30-39 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
40-49 years : female
|
13 participants
n=5 Participants
|
|
Age, Customized
40-49 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
50-59 years : female
|
11 participants
n=5 Participants
|
|
Age, Customized
50-59 years : male
|
2 participants
n=5 Participants
|
|
Age, Customized
60-69 years : female
|
13 participants
n=5 Participants
|
|
Age, Customized
60-69 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
70-79 years : female
|
3 participants
n=5 Participants
|
|
Age, Customized
70-79 years : male
|
0 participants
n=5 Participants
|
|
Age, Customized
80-89 years : female
|
1 participants
n=5 Participants
|
|
Age, Customized
80-89 years : male
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Baseline Participants who completed study
18-21 years : female
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
18-21 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
22-29 years : female
|
2 Participants
n=5 Participants
|
|
Baseline Participants who completed study
22-29 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
30-39 years : female
|
5 Participants
n=5 Participants
|
|
Baseline Participants who completed study
30-39 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
40-49 years : female
|
13 Participants
n=5 Participants
|
|
Baseline Participants who completed study
40-49 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
50-59 years : female
|
5 Participants
n=5 Participants
|
|
Baseline Participants who completed study
50-59 years : male
|
2 Participants
n=5 Participants
|
|
Baseline Participants who completed study
60-69 years : female
|
11 Participants
n=5 Participants
|
|
Baseline Participants who completed study
60-69 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
70-79 years : female
|
2 Participants
n=5 Participants
|
|
Baseline Participants who completed study
70-79 years : male
|
0 Participants
n=5 Participants
|
|
Baseline Participants who completed study
80-89 years : female
|
1 Participants
n=5 Participants
|
|
Baseline Participants who completed study
80-89 years : male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hrs, 48 hrs, 72 hrs and 120 hrsPopulation: Those that completed the current study
Composite measure consisting of complete response (CR), defined as no emetic episode and no rescue medication; the proportions of patients with no emesis and no additional rescue medication in the 120 hours following the completion of surgical procedure.
Outcome measures
| Measure |
Admnistration of Granisetron
n=41 Participants
Outcomes measured in the study patients after application of transdermal granisetron patch throughout the study period
|
|---|---|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Completed Response : 24 hrs
|
8 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Completed Response : 48 hrs
|
25 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Completed Response : 72 hrs
|
24 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Completed Response : 120 hrs
|
28 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
No PONV symptoms : 24 hrs
|
18 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
No PONV symptoms : 48 hrs
|
25 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
No PONV symptoms : 72 hrs
|
24 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
No PONV symptoms : 120 hrs
|
28 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Nausea : 24 hrs
|
21 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Nausea : 48 hrs
|
11 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Nausea : 72 hrs
|
7 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Nausea : 120 hrs
|
3 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Vomiting with or without retching : 24 hrs
|
5 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Vomiting with or without retching : 48 hrs
|
2 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Vomiting with or without retching : 72 hrs
|
0 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Vomiting with or without retching : 120 hrs
|
0 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Retching (dry-hives, without vomiting) : 24 hrs
|
3 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Retching (dry-hives, without vomiting) : 48 hrs
|
1 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Retching (dry-hives, without vomiting) : 72 hrs
|
0 Participants
|
|
Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea
Retching (dry-hives, without vomiting) : 120 hrs
|
0 Participants
|
Adverse Events
Admnistration of Granisetron
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Admnistration of Granisetron
n=50 participants at risk
Preoperative administration of granisetron transdemal patch
granisetron: Application granisetron transdermal patch preoperatively
|
|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
12.0%
6/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
Gastrointestinal disorders
constipation
|
4.0%
2/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
Gastrointestinal disorders
diarrhea
|
2.0%
1/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
Nervous system disorders
hallucination
|
2.0%
1/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
General disorders
dizziness
|
2.0%
1/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
General disorders
headache
|
2.0%
1/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
|
Cardiac disorders
EKG changes
|
2.0%
1/50 • 120 hours
Granisetron transdermal patch is already FDA approved for treatment of patients with cancer during chemotherapy but has not been tested for treating PONV caused by general anesthesia.
|
Additional Information
Dr. Piotr Janicki
The Pennsylvania State University College of Medicine
Phone: 7175315680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place