Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410943
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SRSlow-release Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Randomized Double-Blind Repeated Dose Parallel-Group Comparison of the Efficacy Tolerability of Dilaudid SR Tablets and Immediate Release Dilaudid 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 a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI to demonstrate comparable efficacy of OROS hydromorphone HCI SR slow release and hydromorphone HCI IR immediate release following administration of approximately equivalent total daily doses and demonstrate a significant dose-response relationship between OROS hydromorphone HCI SR slow release for breakthrough pain medication use or alternatively diary-based analgesic scores
Detailed Description:
This was a randomized patients are assigned different treatments based on chance double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage repeated-dose three-arm parallel group study conducted in three phases Following a Prior Opioid Stabilization Phase wherein patients were required to be on a stable dose of chronic opioid therapy patients were converted titrated and stabilized on hydromorphone HCI IR immediate release to achieve acceptable levels of analgesia in the Open-Label Hydromorphone HCI IR immediate release Conversion Titration and Stabilization Phase Supplementary hydromorphone HCI IR immediate release was provided for breakthrough pain and patients were considered stabilized on hydromorphone HCI IR immediate release when the total daily dose of hydromorphone HCI IR immediate release remained unchanged with no more than three hydromorphone HCI IR immediate release breakthrough pain medication doses per day for 2 consecutive days Patients who were able to achieve a stable total daily dose of at least 20 mg but not more than 60 mg of hydromorphone HCI IR immediate release exclusive of breakthrough pain medication within the 14 day Open-Label hydromorphone HCI IR immediate release Conversion Titration and Stabilization Phase of the study entered the Double-Blind Randomized Repeat Dosing Phase of the study Patients were randomized to receive 7 days of either OROS hydromorphone HCI SR slow release at a daily dose approximately equal to their stabilized total daily dose of hydromorphone HCI IR immediate release OROS hydromorphone HCI SR slow release at a daily dose approximately equal to one-half their stabilized total daily dose of hydromorphone HCI IR immediate release 12 OROS hydromorphone slow release or hydromorphone HCI IR immediate release at the same daily dose on which they were stabilized hydromorphone immediate release Patients who completed the study were eligible for participation in an open-label OROS hydromorphone SR slow release long-term extension study Protocol DO-109 OROS hydromorphone slow release 8 16 and 32 mg tablets hydromorphone immediate release 2 and 4 mg tablets placebo immediate release 2 and 4 mg tablets and placebo slow release 8 16 and 32 mg tablets taken orally for 7 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