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Trial record 29 of 326 for:    clonidine

Use of Transdermal Clonidine in Trauma Patients

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ClinicalTrials.gov Identifier: NCT01139996
Recruitment Status : Terminated (Difficulty in enrolling participants)
First Posted : June 9, 2010
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Health University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Delirium
Interventions Drug: Clonidine
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transdermal Clonidine/Oral Clonidine Comparator
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Transdermal Clonidine/Oral Clonidine Comparator Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
baseline data were not collected
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo
Hide Description data were not collected
Time Frame 2 or more years
Hide Outcome Measure Data
Hide Analysis Population Description
data were not collected
Arm/Group Title Transdermal Clonidine/Oral Clonidine Comparator
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Incidence and Duration in Hours of Delirium Currently Used
Hide Description As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected
Time Frame 2 or more years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo
Hide Description Hours. data were not collected
Time Frame 2 or more years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Mean Incidence and Duration of Delirium
Hide Description As assessed by daily CAM score currently used. data were not collected
Time Frame 2 or more years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description data were not collected
 
Arm/Group Title Transdermal Clonidine/Oral Clonidine Comparator
Hide Arm/Group Description

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

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

All-Cause Mortality
Transdermal Clonidine/Oral Clonidine Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Clonidine/Oral Clonidine Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transdermal Clonidine/Oral Clonidine Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Imran Siddiqui, MD
Organization: Memorial University Medical Center
Phone: 912-350-8707
EMail: research2@memorialhealth.com
Layout table for additonal information
Responsible Party: Memorial Health University Medical Center
ClinicalTrials.gov Identifier: NCT01139996     History of Changes
Other Study ID Numbers: MHUMC-2010-04-02
First Submitted: June 7, 2010
First Posted: June 9, 2010
Results First Submitted: March 27, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017