Gregory Hammer
HMP PK PD study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a multicenter, inpatient, open-label within subject dose titration study to characterize the pharmacokinetics / pharmacodynamics, safety and efficacy of hydromorphone HCl oral solution in subjects from 28 days to 16 years of age, inclusive, who require opioid analgesics for post-operative pain. The primary objective is to characterize the pharmacokinetics and pharmacodynamics (using a population pharmacokinetics [PK]/pharmacodynamic [PD] approach) of hydromorphone hydrochloride oral solution. The secondary objectives are to characterize its safety and efficacy.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: pain
Phase:
Phase 2Eligibility
Ages Eligible for Study:
28 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) male and female pediatric subjects from 28 days to 16 years of age;
2)prospective subjects anticipated to have acute, post operative pain requiring oral opioid analgesics for at least 24-
48 hours following post-operative parenteral analgesia;
3) prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Key Exclusion Criteria:
1) prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve;
2) prospective subjects who have received opioid analgesic therapy other than with hydromorphone HCl or morphine sulfate during the 48-hour post-operative period prior to administration of first dose of oral study drug;
3) prospective subjects who have received regional anesthetic blockade OR analgesic treatment with non-opioid medications within 6 hours prior to administration of first dose of oral study drug;
4) prospective subjects who have received treatment with morphine sulfate administered via the neuraxial route
during the 24-hour period prior to administration of first dose of oral study drug.
Additional Study Details
Official Title:
A Multicenter, Inpatient, Open-Label, Within Subject Dose Titration Study to Characterize the Pharmacokinetics / Pharmacodynamics, Safety and Efficacy of Hydromorphone HCl Oral Solution in Subjects from 28 Days to 16 Years of Age, Inclusive, Who Require Opioid Analgesics for Post-Operative PainAnticipated start date:
4/1/2007Lead Sponsor:
Purdue PharmaInvestigator(s):
- Gregory Hammer
- Stephen J. Roth M.D., M.P.H.
- Deborah Franzon
- James P Andrus
- Saraswati Kache MD
- Hong Cao
- Ava M. Eagle
- Marilou Sugimoto
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Pharmacokinetics/dynamicsPrimary Outcomes:
- PK
- PD
Secondary Outcomes:
- safety
- efficacy
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
60More Information
Secondary ID(s):
- 8050
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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