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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598702
First Posted: January 22, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallinckrodt
Results First Submitted: September 25, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pain
Fever
Intervention: Drug: IV Acetaminophen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No subjects were entered into the "Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h" group

Reporting Groups
  Description
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours

Participant Flow:   Overall Study
    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
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 
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.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 1   3   7   33   9   42   1   4   100 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)   [ Time Frame: First dose to end of treatment period ]

2.  Primary:   Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event   [ Time Frame: First dose to 30 days after last dose ]

3.  Secondary:   Subject's (Parent/Guardian) Global Evaluation of Study Treatment   [ Time Frame: Day 0 to Day 5, Day 7 or Early Termination from study ]

4.  Secondary:   Physician's Global Assessment of Study Treatment   [ Time Frame: End of study or Early Termination ]


  Serious Adverse Events
  Hide Serious Adverse Events

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.
Additional Description Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.

Reporting Groups
  Description
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h 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): IV APAP 6.7 - 12.5 mg/kg q4h 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): IV APAP 10 - 15 mg/kg q6h Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours

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
Total, Serious Adverse Events                 
# participants affected / at risk   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                 
# participants affected / at risk   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 [3]                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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 [4]                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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%) 
# events               0   0       
Postoperative wound infection * 1                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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%) 
# events               0   0       
Diaphragmatic disorder * 1                 
# participants affected / at risk   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%) 
# events               0   0       
Obstructive airways disorder * 1                 
# participants affected / at risk   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                 
# participants affected / at risk   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                 
# participants affected / at risk   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%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDra (10.0)
[3] Exacerbation of Hirschsprung's Disease
[4] Accidental dislodgement of suprapubic cathether




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lawrence Hill, VP Clinical Development
Organization: Mallinckrodt Pharmaceuticals
phone: 908-238-6370
e-mail: lawrence.hill@mallinckrodt.com



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