Gregory Hammer
IV APAP PK study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
It is a prospective, multi-center, randomized, open-label, single and repeated Dose, 48 hour study of intravenous Acetaminophen in pediatric inpatients to determine pharmacokinetics and safety and efficacy in acute pain and fever. The study objectives are 1. define the single and multiple dose pharmacokinetics (PK) of IV APAP given at various dosing regimens in pediatric inpatient populations: 12.5 mg/kg q6 hours or 15 mg/kg q8 hours in neonates and 12.5 mg/kg q4 hours or 15 mg/kg q6 hours in infants, children and adolescents 2. assess the safety and efficacy of repeated doses of IV APAP given under various dosing regimens on reducing pain intensity or temperature in pediatric inpatients
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: pain
Phase:
Phase 2Eligibility
Ages Eligible for Study:
1 days to 16 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1) Provide written Informed consent/Assent prior to participation in the Study
2) Age strata:
? Full-term Neonates
? Infants (29 days to <2 yrs old)
o 29 days to <6 months
o 6 to <12 months
o 12 to <24 months)
? Children (2 yrs to <12 yrs old)
? Adolescents (12 yrs to equal or less than 16 yrs old)
3) Inpatient status: are currently inpatients or have an admission scheduled and will soon become
an inpatient (e.g., elective surgery)
4) Diagnosis: requires or will require analgesic treatment for acute pain or antipyretic treatment for fever
5) IV access: have a need for IV access for the duration of the Study either due to a nothing by mouth (NPO) status or due to the Investigator?s assessment that oral treatment is not optimal (for
example, severe nausea or vomiting)
6) Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject?s Parent or Guardian must meet this criterion)
7) Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator after completing the screening assessment, make Study participation inadvisable
8) If a female of child bearing potential, have a negative pregnancy test
Key Exclusion Criteria:
1) Is not able to comply with the plasma sampling requirements of the Study
2) Has known or suspected hypersensitivity to acetaminophen or the inactive excipients of IV APAP
3) Has been taking any acetaminophen-containing product in the 12 hours prior or any of the following in the 48 hours prior to randomization in the Study: probenecid, disulfiram, isoniazide, St. John?s wort, skullcap, chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, and valerian
4) Has any significant medical condition that in the opinion of the Investigator contraindicates participation in the Study
5) Does not have the ability to communicate with the Study staff or complete Study activities.
Parent/Guardian must be able to effectively communicate with Study staff if the Subject is preverbal.
6) Has impaired liver function, with evidence of clinically significant liver disease, or other condition that may suggest the potential for an increased susceptibility to hepatic toxicity with
IV APAP exposure. For this criterion, a total bilirubin >1.5 times upper limit of normal (ULN) for age or an ALT (SGPT) or AST (SGOT) >2.5 times ULN for age will be deemed as evidence of clinically significant (Common Terminology Criteria for Adverse Events [CTCAE] Grade 2) liver dysfunction or disease.
7) Has significantly impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula) calculated to be less than 1/3rd of normal for the applicable age strata
8) Has participated in another interventional clinical Study (investigational or marketed product)
within 30 days of the planned Study randomization date
Additional Study Details
Official Title:
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics and Safety and Efficacy in Acute Pain and FeverAnticipated start date:
4/1/2008Lead Sponsor:
Cadence IncInvestigator(s):
- Gregory Hammer
- Elliot J. Krane
- Stephen J. Roth M.D., M.P.H.
- Emily Ann Wessler
- Saraswati Kache MD
- Karen L. Booth
- Deborah Franzon
- James P Andrus
- Hong Cao
- Ava M. Eagle
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
PharmacokineticsPrimary Outcomes:
- PK
Secondary Outcomes:
- LFTs
- efficacy evaluation
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 12296
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/10/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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