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Trial record 44 of 58475 for:    Placebo

Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

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ClinicalTrials.gov Identifier: NCT00493311
Recruitment Status : Completed
First Posted : June 28, 2007
Results First Posted : September 21, 2010
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fever
Interventions Drug: IV Placebo
Drug: IV Acetaminophen
Biological: Reference Standard Endotoxin (RSE)
Enrollment 60
Recruitment Details Subjects were recruited at a single clinical research facility in the United States during July to September 2007.
Pre-assignment Details Eligible subjects received intravenous endotoxin to induce fever and were then randomized to receive either 1 g acetaminophen in 100 ml intravenous solution or 100 ml placebo solution.
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Period Title: Overall Study
Started 29 31
Completed 27 29
Not Completed 2 2
Reason Not Completed
Need for rescue medication             2             2
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g Total
Hide Arm/Group Description After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution Total of all reporting groups
Overall Number of Baseline Participants 29 31 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
31
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 31 participants 60 participants
30.0  (10.02) 29.7  (7.35) 29.9  (8.67)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
29
 100.0%
31
 100.0%
60
 100.0%
[1]
Measure Description: Only male subjects were allowed to participate in the study.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 31 participants 60 participants
29 31 60
1.Primary Outcome
Title Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever
Hide Description The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.
Time Frame Baseline (T0) to 6 hours post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description:
After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
-0.7  (3.32) -3.7  (3.58)
2.Secondary Outcome
Title Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.
Hide Description WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.
Time Frame Baseline (T0) to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description:
After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
0.7  (1.36) -0.9  (1.35)
3.Secondary Outcome
Title Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)
Hide Description [Not Specified]
Time Frame Baseline (T0) to 360 minutes (6 hours) post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description:
After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Overall Number of Participants Analyzed 29 31
Mean (Standard Deviation)
Unit of Measure: Degrees celsius
-0.9  (0.75) -1.3  (0.65)
4.Secondary Outcome
Title The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)
Hide Description [Not Specified]
Time Frame 360 minutes (6 hours after study drug administration)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description:
After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: Percentage of participants
3 13
5.Secondary Outcome
Title Global Assessment of Treatment at T360 Minutes or Early Termination.
Hide Description

Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor

  1. = Fair
  2. = Good
  3. = Excellent
Time Frame Baseline (T0) to 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description:
After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
Overall Number of Participants Analyzed 29 31
Measure Type: Number
Unit of Measure: participants
Rate treatment as 'poor' 2 1
Rate treatment as 'fair' 9 5
Rate treatment as 'good' 10 16
Rate treatment as 'excellent' 8 9
Time Frame Treatment Emergent Adverse Events(TEAEs)were reported from T0 (on or after the start of study medication) to 6 hours after study medication was administered to the subject.
Adverse Event Reporting Description TEAEs are adverse events that start on or after the study medication is given to the subject.
 
Arm/Group Title Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Hide Arm/Group Description After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
All-Cause Mortality
Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intravenous (IV) Placebo Intravenous (IV) Acetaminophen 1 g
Affected / at Risk (%) Affected / at Risk (%)
Total   13/29 (44.83%)   14/31 (45.16%) 
Gastrointestinal disorders     
Diarrhoea * 1  3/29 (10.34%)  1/31 (3.23%) 
Nausea * 1  4/29 (13.79%)  2/31 (6.45%) 
Vomiting * 1  3/29 (10.34%)  1/31 (3.23%) 
General disorders     
Mucosal dryness * 1  2/29 (6.90%)  1/31 (3.23%) 
Investigations     
Alanine aminotransferase increased * 1  6/29 (20.69%)  5/31 (16.13%) 
Aspartate aminotransferase increased * 1  4/29 (13.79%)  6/31 (19.35%) 
Blood bilirubin increased * 1  1/29 (3.45%)  3/31 (9.68%) 
Gamma-glutamyltransferase increased * 1  8/29 (27.59%)  5/31 (16.13%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/29 (6.90%)  1/31 (3.23%) 
Nervous system disorders     
Dizziness * 1  2/29 (6.90%)  2/31 (6.45%) 
Headache * 1  3/29 (10.34%)  0/31 (0.00%) 
Somnolence * 1  2/29 (6.90%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Investigator may publish only after cooperative publication or 18 months after sponsor's final evaluation of study data, whichever occurs first. At least 60 days prior to submission for publication, investigator must submit manuscript to sponsor for review and comment. Sponsor has 60 day period thereafter to respond with comment. Investigator will remove confidential information at the request of sponsor.
Results Point of Contact
Name/Title: Lawrence Hill
Organization: Mallinckrodt Pharmaceuticals
Phone: (908) 238-6370
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00493311     History of Changes
Other Study ID Numbers: CPI-APF-302
First Submitted: June 27, 2007
First Posted: June 28, 2007
Results First Submitted: September 25, 2009
Results First Posted: September 21, 2010
Last Update Posted: October 19, 2016