Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410878
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2006-12-12
Brief Title:
A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI Slow Release Tablets in Patients With Chronic Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets Hydromorphone HCI in Patients With Chronic Pain
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to characterize the steady-state pharmacokinetic metabolism and action profile of OROS hydromorphone HCI slow release in patients who required opioid therapy on a daily basis for chronic pain conditions Patients stabilized on prior opioids were converted to OROS hydromorphone slow release and titrated slowly increased or decreased to adequate analgesia pain relief They were maintained at that dose for 4-10 days and had blood samples drawn over 24 hours on the last day of study
Detailed Description:
This was an open-label repeated-dose study involving patients who required opioid therapy on a daily basis for chronic pain conditions In this study baseline evaluations were performed at Visit 1 Patients were given a diary in which to record daily opioid medication use and daily pain-relief ratings throughout the study During the time between Visit 1 and Visit 2 patients continued taking their prior oral or transdermal opioid medication for pain Patients were considered stabilized when during usual activity the total daily dose of baseline medication remained unchanged with no more than three opioid breakthrough pain medication dosesday administered for two consecutive days Patients returned within 1 week of Visit 1 for Visit 2 During this visit patients 24-hour baseline oral opioid dose was converted to hydromorphone at a conversion ratio of approximately 51 oral morphine sulfate to oral hydromorphone HCI mg equivalents Patients were dispensed OROS hydromorphone HCI slow release tablets and were then increased to acceptable analgesia pain relief Eligible stabilized patients requiring a total daily dose of at least 8 mg but no more than 64 mg of OROS hydromorphone HCI slow release exclusive of breakthrough medication began the 5-10 day maintenance therapy phase at Visit 3 Morphine sulfate immediate-release tablets were provided as breakthrough pain medication Patients returned to the clinic in the morning following a minimum of 4 days of continuous OROS hydromorphone HCI slow release therapy at a constant daily dose for Visit 4 Upon arrival at the clinic an initial trough blood sample was taken prior to witnessed administration of the usual dosage of OROS hydromorphone HCI slow release The exact time of the drug administration was documented Patients were instructed to return the following morning and not to consume food or beverage within 3 hours of their scheduled visit Patients were instructed not to self administer their OROS hydromorphone HCI slow release the following morning they were dosed in the clinic Patients could take immediate release morphine sulfate as needed Patients returned to the clinic the next morning visit 5 and remained for a 24-hour period for witnessed dosing and plasma blood sampling for pharmacokinetic metabolismaction analysis Dosing and plasma blood sampling began 24 hours following the time of dosing at the clinic the previous day Water 240 mL was taken with the medication Immediately prior to each blood draw patients rated their pain intensity using an 11-point scale and rated their pain intensity from 0 no pain to 10 pain as bad as you can imagine Blood samples for analysis were drawn at 0 prior to dosing 124681012151821 and 24 hours after dosing Urine output was collected over the 24-hour period from selected patients Vital signs were taken At the conclusion of Visit 5 or in the event of early study termination a Global Evaluation and physical examination were performed The patients diary was reviewed with the patient and all unused study medication was collected Safety assessments included vital signs and physical examination at the start and end of study OROS Hydromorphone HCL slow release 81632and 64 mg tablets orally Patients were stabilized on prior opioids then converted to OROS Hydromorphone HCL slow release and slowly increased or decreased to adequate analgesia Then the patients were maintained at that dose for 4 - 10 days Duration of treatment was up to 31 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None