Trial Outcomes & Findings for Use of Transdermal Clonidine in Trauma Patients (NCT NCT01139996)
NCT ID: NCT01139996
Last Updated: 2017-06-14
Results Overview
data were not collected
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
2 or more years
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Transdermal Clonidine/Oral Clonidine
An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours
Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours
|
Comparator
Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet
Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Transdermal Clonidine in Trauma Patients
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 2 or more yearsPopulation: data were not collected
data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 or more yearsAs assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 or more yearsHours. data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 or more yearsAs assessed by daily CAM score currently used. data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Transdermal Clonidine/Oral Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place