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Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

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ClinicalTrials.gov Identifier: NCT00598702
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : January 6, 2011
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Fever
Intervention Drug: IV Acetaminophen
Enrollment 100
Recruitment Details Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008
Pre-assignment Details No subjects were entered into the "Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h" group
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Period Title: Overall Study
Started 1 3 7 33 9 42 1 4
Completed 1 [1] 1 [1] 5 [1] 25 [1] 6 [1] 30 [1] 0 [1] 4 [1]
Not Completed 0 2 2 8 3 12 1 0
Reason Not Completed
Not specified             0             2             0             0             0             1             0             0
Early discharge from hospital             0             0             2             5             0             10             1             0
Adverse Event             0             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             1             1             0             0             0
Physician Decision             0             0             0             0             1             0             0             0
Dose limiting toxicity             0             0             0             1             1             1             0             0
[1]
Completed treatment period per requirements of protocol version under which the subject enrolled.
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h Total
Hide Arm/Group Description Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours Total of all reporting groups
Overall Number of Baseline Participants 1 3 7 33 9 42 1 4 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 7 participants 33 participants 9 participants 42 participants 1 participants 4 participants 100 participants
<=18 years
1
 100.0%
3
 100.0%
7
 100.0%
33
 100.0%
9
 100.0%
42
 100.0%
1
 100.0%
4
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 7 participants 33 participants 9 participants 42 participants 1 participants 4 participants 100 participants
Female
0
   0.0%
2
  66.7%
5
  71.4%
17
  51.5%
6
  66.7%
29
  69.0%
0
   0.0%
3
  75.0%
62
  62.0%
Male
1
 100.0%
1
  33.3%
2
  28.6%
16
  48.5%
3
  33.3%
13
  31.0%
1
 100.0%
1
  25.0%
38
  38.0%
1.Primary Outcome
Title Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description A TEAE is defined as an adverse event that starts on or after the start of study medication.
Time Frame First dose to end of treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description:
Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Number of Participants Analyzed 1 3 7 33 9 42 1 4
Measure Type: Number
Unit of Measure: Subjects
1 1 5 25 9 35 0 2
2.Primary Outcome
Title Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
Hide Description

A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;

  • results in death
  • is life-threatening
  • requires inpatient hospitalization or causes prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • is a congenital anomaly/birth defect
  • is an important medical event
Time Frame First dose to 30 days after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description:
Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Number of Participants Analyzed 1 3 7 33 9 42 1 4
Measure Type: Number
Unit of Measure: Subjects
1 1 0 13 2 3 0 1
3.Secondary Outcome
Title Subject's (Parent/Guardian) Global Evaluation of Study Treatment
Hide Description Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).
Time Frame Day 0 to Day 5, Day 7 or Early Termination from study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description:
Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Number of Participants Analyzed 1 3 7 33 9 42 1 4
Measure Type: Number
Unit of Measure: participants
Poor 0 0 0 0 0 0 0 0
Fair 0 0 0 0 1 2 0 0
Good 0 3 1 11 3 17 0 1
Excellent 1 0 6 17 5 23 1 2
Missing 0 0 0 5 0 0 0 1
4.Secondary Outcome
Title Physician's Global Assessment of Study Treatment
Hide Description Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).
Time Frame End of study or Early Termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description:
Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Number of Participants Analyzed 1 3 7 33 9 42 1 4
Measure Type: Number
Unit of Measure: participants
Poor 0 0 0 0 0 0 0 0
Fair 0 0 0 0 0 1 0 0
Good 0 2 1 15 4 16 0 1
Excellent 1 1 6 13 5 25 1 2
Missing 0 0 0 5 0 0 0 1
Time Frame Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period.
Adverse Event Reporting Description Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
 
Arm/Group Title Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Hide Arm/Group Description Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
All-Cause Mortality
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/3 (33.33%)      0/7 (0.00%)      13/33 (39.39%)      2/9 (22.22%)      3/42 (7.14%)      0/1 (0.00%)      1/4 (25.00%)    
Cardiac disorders                 
Hypotension * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Congenital, familial and genetic disorders                 
Congenital Megacolon * 1 [1]  1/1 (100.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders                 
Intestinal obstruction * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
General disorders                 
Pyrexia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Catheter-Related Complication * 1 [2]  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders                 
Hepatotoxicity * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Infections and infestations                 
Abdominal abscess * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0 0/42 (0.00%)  0 0/1 (0.00%)  0/4 (0.00%) 
Postoperative wound infection * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Wound Infection * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Investigations                 
Hepatic enzyme increased * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Nervous system disorders                 
Headache * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Neuralgia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders                 
Renal failure acute * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Chylothorax * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0 0/42 (0.00%)  0 0/1 (0.00%)  0/4 (0.00%) 
Diaphragmatic disorder * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0 0/42 (0.00%)  0 0/1 (0.00%)  0/4 (0.00%) 
Obstructive airways disorder * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Pneumonia aspiration * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Respiratory failure * 1  0/1 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra (10.0)
[1]
Exacerbation of Hirschsprung's Disease
[2]
Accidental dislodgement of suprapubic cathether
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/3 (33.33%)      5/7 (71.43%)      24/33 (72.73%)      9/9 (100.00%)      33/42 (78.57%)      0/1 (0.00%)      2/4 (50.00%)    
Blood and lymphatic system disorders                 
Anemia * 1  0/1 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  2/33 (6.06%)  0/9 (0.00%)  2/42 (4.76%)  0/1 (0.00%)  0/4 (0.00%) 
Cardiac disorders                 
Tachycardia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Ear and labyrinth disorders                 
Ear Pain * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders                 
Constipation * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  11/33 (33.33%)  2/9 (22.22%)  10/42 (23.81%)  0/1 (0.00%)  1/4 (25.00%) 
Diarrhoea * 1  0/1 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  3/33 (9.09%)  0/9 (0.00%)  2/42 (4.76%)  0/1 (0.00%)  0/4 (0.00%) 
Nausea * 1  0/1 (0.00%)  0/3 (0.00%)  3/7 (42.86%)  6/33 (18.18%)  5/9 (55.56%)  17/42 (40.48%)  0/1 (0.00%)  0/4 (0.00%) 
Vomiting * 1  0/1 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  7/33 (21.21%)  4/9 (44.44%)  10/42 (23.81%)  0/1 (0.00%)  1/4 (25.00%) 
Abdominal Distension * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Abdominal Pain * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  1/33 (3.03%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
General disorders                 
Inflammation * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Pyrexia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  7/33 (21.21%)  0/9 (0.00%)  3/42 (7.14%)  0/1 (0.00%)  0/4 (0.00%) 
Infusion Site Reaction * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Oedema Peripheral * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/33 (9.09%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Infections and infestations                 
Abdominal abscess * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Upper Respiratory Tract Infection * 1  0/1 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Cellulitis * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vulvovaginal Mycotic Infection * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Investigations                 
Sputum culture positive * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Gamma-Glutamyltransferase (GGT) Increased * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders                 
Hypoalbuminemia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  4/33 (12.12%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hypokalemia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Hypophosphatemia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  1/42 (2.38%)  0/1 (0.00%)  1/4 (25.00%) 
Hypervolaemia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  2/42 (4.76%)  0/1 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Muscle spasms * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  2/9 (22.22%)  4/42 (9.52%)  0/1 (0.00%)  0/4 (0.00%) 
Arthralgia * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Back Pain * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Nervous system disorders                 
Headache * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  3/9 (33.33%)  4/42 (9.52%)  0/1 (0.00%)  0/4 (0.00%) 
Dizziness * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  3/42 (7.14%)  0/1 (0.00%)  0/4 (0.00%) 
Sedation * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Psychiatric disorders                 
Agitation * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/33 (9.09%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  2/4 (50.00%) 
Insomnia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Renal and urinary disorders                 
Oliguria * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Polyuria * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Urinary Retention * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Laryngotracheal oedema * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Pleural effusion * 1  0/1 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  1/42 (2.38%)  0/1 (0.00%)  0/4 (0.00%) 
Pulmonary oedema * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Stridor * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/33 (9.09%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Wheezing * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  2/4 (50.00%) 
Apnoea * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Atelectasis * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Epistaxis * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Hypoxia * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  2/9 (22.22%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Pharyngolaryngeal Pain * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders                 
Pruritis * 1  0/1 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  5/33 (15.15%)  4/9 (44.44%)  4/42 (9.52%)  0/1 (0.00%)  0/4 (0.00%) 
Skin disorder * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Skin irritation * 2  1/1 (100.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Rash * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/33 (6.06%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Rash Generalised * 1  0/1 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/33 (0.00%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Surgical and medical procedures                 
Wound Drainage * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/33 (0.00%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  0/4 (0.00%) 
Vascular disorders                 
Hypertension * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/33 (3.03%)  0/9 (0.00%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
Hypotension * 1  0/1 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  5/33 (15.15%)  1/9 (11.11%)  0/42 (0.00%)  0/1 (0.00%)  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA 10.0
The original protocol required 50 subjects that completed 5 days of treatment. With protocol amendment 2, the criteria for enrollment/completion was reduced to 1 day of treatment. Subjects were required to have a minimum of 3 IV APAP doses per day.
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.
The Investigator may publish 18 months after Cadence's final evaluation of all study data from all sites, whichever occurs first.Manuscripts/abstracts will be provided to Cadence for review and comment at least 30 days prior to submission.Cadence shall have 30 days to respond with comments.
Results Point of Contact
Name/Title: Lawrence Hill, VP Clinical Development
Organization: Mallinckrodt Pharmaceuticals
Phone: 908-238-6370
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00598702     History of Changes
Other Study ID Numbers: CPI-APA-352
First Submitted: January 9, 2008
First Posted: January 22, 2008
Results First Submitted: September 25, 2009
Results First Posted: January 6, 2011
Last Update Posted: May 10, 2017