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Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

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ClinicalTrials.gov Identifier: NCT00875550
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : October 30, 2014
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sedation
Interventions Drug: Dexmedetomidine
Drug: Midazolam
Drug: Fentanyl
Drug: Morphine
Enrollment 175

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Period Title: Overall Study
Started 89 86
Completed 77 76
Not Completed 12 10
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose Total
Hide Arm/Group Description

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Total of all reporting groups
Overall Number of Baseline Participants 89 86 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 86 participants 175 participants
2.35  (3.437) 2.85  (4.172) 2.60  (3.814)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 86 participants 175 participants
<=18 years
89
 100.0%
86
 100.0%
175
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 86 participants 175 participants
>= 1 month to < 24 months 63 60 123
>=24 months to < 17 years old 26 26 52
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 86 participants 175 participants
Female
36
  40.4%
38
  44.2%
74
  42.3%
Male
53
  59.6%
48
  55.8%
101
  57.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 86 participants 175 participants
American Indian or Alaska Native
3
   3.4%
3
   3.5%
6
   3.4%
Asian
0
   0.0%
2
   2.3%
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.2%
1
   0.6%
Black or African American
14
  15.7%
14
  16.3%
28
  16.0%
White
64
  71.9%
62
  72.1%
126
  72.0%
More than one race
1
   1.1%
1
   1.2%
2
   1.1%
Unknown or Not Reported
7
   7.9%
3
   3.5%
10
   5.7%
American Society of Anaesthesiologists (ASA) classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 86 participants 175 participants
P1 - Normal healthy patient (PT) 3 5 8
P2 - PT w/ mild systemic disease 28 16 44
P3 - PT w/ severe systemic disease) 50 53 103
P4 - PT w/ constant threat to life) 8 12 20
P5 - Moribund patient 0 0 0
P6 - A declared brain-dead patient 0 0 0
1.Primary Outcome
Title Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.
Hide Description

Clinical Score Level of Sedation 0 Awake/Alert

  1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.
  2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.
  3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation.
  4. Unarousable
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Overall Number of Participants Analyzed 83 81
Measure Type: Number
Unit of Measure: Percentage of subjects
44.6 54.3
2.Secondary Outcome
Title Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated
Hide Description [Not Specified]
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Overall Number of Participants Analyzed 83 81
Median (Full Range)
Unit of Measure: Hours
17.2
(5 to 24)
17.3
(2 to 24)
3.Secondary Outcome
Title Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated
Hide Description [Not Specified]
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Overall Number of Participants Analyzed 83 81
Median (Full Range)
Unit of Measure: hours
1.0
(0 to 10)
0.7
(0 to 14)
4.Secondary Outcome
Title Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated
Hide Description [Not Specified]
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Overall Number of Participants Analyzed 83 81
Mean (Standard Deviation)
Unit of Measure: Milligram
Midazolam 2.221  (4.6089) 1.241  (2.3052)
Fentanyl 45.225  (83.7743) 44.367  (112.13)
Morphine 1.446  (3.2978) 1.141  (2.4209)
5.Secondary Outcome
Title Time to First Dose of Rescue Medication for Sedation and Analgesia
Hide Description [Not Specified]
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Overall Number of Participants Analyzed 83 81
Median (95% Confidence Interval)
Unit of Measure: Hours
1.6
(0.933 to 3.383)
2.0
(1.067 to 3.750)
6.Secondary Outcome
Title Time to Successful Extubation
Hide Description [Not Specified]
Time Frame 6 to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description:

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores

Overall Number of Participants Analyzed 83 81
Median (95% Confidence Interval)
Unit of Measure: Hours
23.8 [1] 
(18.550 to NA)
20.5
(17.133 to 23.333)
[1]
Computation for the 95% confidence interval (CI) from the Kaplan-Meier analysis requires adequate number of events to be estimable. There were not enough events to fully characterize the complete CI, only point estimate and the 95% lower CI estimate.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Low Dose Dexmedetomidine High Dose
Hide Arm/Group Description

Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)

Midazolam: Rescue medication for sedation according to UMSS scores

Fentanyl: Rescue medication for pain based on UMSS scores

Morphine: Rescue medication for pain based on UMSS scores.

All-Cause Mortality
Dexmedetomidine Low Dose Dexmedetomidine High Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine Low Dose Dexmedetomidine High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/89 (1.12%)      1/86 (1.16%)    
Cardiac disorders     
Myocarditis   1/89 (1.12%)  1 0/86 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnoea   0/89 (0.00%)  0 1/86 (1.16%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.1%
Dexmedetomidine Low Dose Dexmedetomidine High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/89 (53.93%)      43/86 (50.00%)    
Blood and lymphatic system disorders     
Anaemia   0/89 (0.00%)  2/86 (2.33%) 
Cardiac disorders     
Bradycardia   2/89 (2.25%)  3/86 (3.49%) 
Extrasystoles   1/89 (1.12%)  0/86 (0.00%) 
Nodal rhythm   1/89 (1.12%)  0/86 (0.00%) 
Tachycardia   0/89 (0.00%)  2/86 (2.33%) 
Ventricular fibrillation   1/89 (1.12%)  0/86 (0.00%) 
Gastrointestinal disorders     
Constipation   1/89 (1.12%)  0/86 (0.00%) 
Diarrhoea   2/89 (2.25%)  0/86 (0.00%) 
Ileus   0/89 (0.00%)  1/86 (1.16%) 
Nausea   3/89 (3.37%)  2/86 (2.33%) 
Vomiting   2/89 (2.25%)  4/86 (4.65%) 
General disorders     
Chest pain   1/89 (1.12%)  0/86 (0.00%) 
Drug withdrawal syndrome   2/89 (2.25%)  0/86 (0.00%) 
General symptom   1/89 (1.12%)  0/86 (0.00%) 
Inflammation   1/89 (1.12%)  0/86 (0.00%) 
Infusion site extravasation   0/89 (0.00%)  1/86 (1.16%) 
Oedema peripheral   0/89 (0.00%)  1/86 (1.16%) 
Pain   1/89 (1.12%)  1/86 (1.16%) 
Pyrexia   7/89 (7.87%)  5/86 (5.81%) 
Infections and infestations     
Parainfluenzae virus infection   1/89 (1.12%)  0/86 (0.00%) 
Staphylococcal infection   0/89 (0.00%)  1/86 (1.16%) 
Urinary tract infection   0/89 (0.00%)  1/86 (1.16%) 
Injury, poisoning and procedural complications     
Device electrical finding   0/89 (0.00%)  1/86 (1.16%) 
Endotracheal intubation complication   0/89 (0.00%)  2/86 (2.33%) 
Investigations     
Activated partial thromboplastin time prolonged   1/89 (1.12%)  0/86 (0.00%) 
Alanine aminotransferase abnormal   1/89 (1.12%)  0/86 (0.00%) 
Base excess decreased   1/89 (1.12%)  0/86 (0.00%) 
Blood albumin abnormal   1/89 (1.12%)  0/86 (0.00%) 
Blood alkaline phosphatase increased   1/89 (1.12%)  0/86 (0.00%) 
Blood cortisol increased   0/89 (0.00%)  1/86 (1.16%) 
Blood culture positive   1/89 (1.12%)  0/86 (0.00%) 
Blood fibrinogen decreased   1/89 (1.12%)  0/86 (0.00%) 
Blood glucose increased   1/89 (1.12%)  1/86 (1.16%) 
Blood magnesium abnormal   1/89 (1.12%)  0/86 (0.00%) 
Blood magnesium decreased   1/89 (1.12%)  1/86 (1.16%) 
Blood pH decreased   2/89 (2.25%)  0/86 (0.00%) 
Blood phosphorus decreased   2/89 (2.25%)  2/86 (2.33%) 
Blood potassium abnormal   1/89 (1.12%)  0/86 (0.00%) 
Blood pressure diastolic decreased   0/89 (0.00%)  1/86 (1.16%) 
Carbon dioxide decreased   1/89 (1.12%)  0/86 (0.00%) 
Central venous pressure decreased   0/89 (0.00%)  1/86 (1.16%) 
Culture positive   0/89 (0.00%)  1/86 (1.16%) 
Culture urine positive   0/89 (0.00%)  1/86 (1.16%) 
Electrocardiogram   1/89 (1.12%)  0/86 (0.00%) 
Electrocardiogram ST segment elevation   0/89 (0.00%)  2/86 (2.33%) 
Haematocrit decreased   2/89 (2.25%)  0/86 (0.00%) 
Haemoglobin decreased   2/89 (2.25%)  0/86 (0.00%) 
Heart rate decreased   0/89 (0.00%)  1/86 (1.16%) 
Heart rate irregular   2/89 (2.25%)  0/86 (0.00%) 
Oxygen saturation decreased   1/89 (1.12%)  3/86 (3.49%) 
PCO2 increased   1/89 (1.12%)  0/86 (0.00%) 
Platelet count decreased   2/89 (2.25%)  0/86 (0.00%) 
Platelet count increased   1/89 (1.12%)  0/86 (0.00%) 
Red blood cell count decreased   1/89 (1.12%)  0/86 (0.00%) 
Respiratory rate decreased   2/89 (2.25%)  0/86 (0.00%) 
Sputum culture positive   1/89 (1.12%)  0/86 (0.00%) 
Urine output decreased   0/89 (0.00%)  2/86 (2.33%) 
White blood cell count increased   0/89 (0.00%)  1/86 (1.16%) 
Metabolism and nutrition disorders     
Acidosis   0/89 (0.00%)  1/86 (1.16%) 
Hyperammonaemia   1/89 (1.12%)  0/86 (0.00%) 
Hyperglycaemia   3/89 (3.37%)  1/86 (1.16%) 
Hypocalcaemia   1/89 (1.12%)  0/86 (0.00%) 
Hypokalaemia   9/89 (10.11%)  5/86 (5.81%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms   1/89 (1.12%)  1/86 (1.16%) 
Nervous system disorders     
Convulsion   1/89 (1.12%)  0/86 (0.00%) 
Crying   1/89 (1.12%)  0/86 (0.00%) 
Status epilepticus   1/89 (1.12%)  0/86 (0.00%) 
Psychiatric disorders     
Agitation   4/89 (4.49%)  5/86 (5.81%) 
Anxiety   2/89 (2.25%)  0/86 (0.00%) 
Insomnia   0/89 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders     
Urinary retention   0/89 (0.00%)  2/86 (2.33%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis   3/89 (3.37%)  4/86 (4.65%) 
Bradypnoea   0/89 (0.00%)  1/86 (1.16%) 
Dyspnoea   1/89 (1.12%)  0/86 (0.00%) 
Haemothorax   0/89 (0.00%)  1/86 (1.16%) 
Nasal congestion   1/89 (1.12%)  0/86 (0.00%) 
Nasal ulcer   1/89 (1.12%)  0/86 (0.00%) 
Pleural effusion   2/89 (2.25%)  3/86 (3.49%) 
Pneumomediastinum   1/89 (1.12%)  0/86 (0.00%) 
Pneumothorax   2/89 (2.25%)  2/86 (2.33%) 
Pulmonary oedema   3/89 (3.37%)  2/86 (2.33%) 
Respiratory acidosis   1/89 (1.12%)  1/86 (1.16%) 
Respiratory tract inflammation   0/89 (0.00%)  1/86 (1.16%) 
Stridor   2/89 (2.25%)  2/86 (2.33%) 
Tachypnoea   0/89 (0.00%)  1/86 (1.16%) 
Wheezing   3/89 (3.37%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis diaper   2/89 (2.25%)  0/86 (0.00%) 
Pruritus   1/89 (1.12%)  0/86 (0.00%) 
Rash   1/89 (1.12%)  0/86 (0.00%) 
Subcutaneous emphysema   1/89 (1.12%)  0/86 (0.00%) 
Vascular disorders     
Hypertension   7/89 (7.87%)  0/86 (0.00%) 
Hypotension   4/89 (4.49%)  7/86 (8.14%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marcelo Garcia de Rocha MD, Global Medical Director
Organization: Hospira
Phone: 224-212-4424
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00875550     History of Changes
Other Study ID Numbers: DEX-08-05
First Submitted: March 31, 2009
First Posted: April 3, 2009
Results First Submitted: May 30, 2014
Results First Posted: October 30, 2014
Last Update Posted: August 14, 2015