Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261495
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2005-12-02
Brief Title:
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone a Strong Opioid in Patients With Chronic Noncancer Pain
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Randomized Open-Label Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy
Status:
COMPLETED
Status Verified Date:
2014-05
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 is to compare the effectiveness and safety of sustained- release hydromorphone formulated to release slowly over time taken once daily and controlled- release oxycodone taken twice daily in patients with chronic non-cancer pain The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone equi-analgesic dosage
Detailed Description:
Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours To counterbalance the drawback of repeated opioid intake sustained-release formulations of oxycodone and hydromorphone were developed that allow twice-daily dosing Subsequently a novel once-daily extended-release hydromorphone formulation was developed to further enhance ease of treatment and improve effectiveness in the treatment of severe pain This is a randomized open-label comparative parallel-group 24-week flexible-dose study in patients with chronic noncancer pain severe enough to require continuous opioid therapy Patients will receive either 8 mg of sustained-release hydromorphone taken once daily or 10 mg of controlled-release oxycodone taken twice daily Individual adjustments in dosing will be performed to achieve satisfactory pain control up to a maximum daily dosage of 32 mg for hydromorphone and 80 mg for oxycodone The primary efficacy outcome will be the determination of the dose of hydromorphone that produces a level of pain control that is equal to the pain control provided by oxycodone equi-analgesic dose Safety will be monitored throughout the study The study hypothesis is that sustained-release hydromorphone taken once daily is well tolerated and is not inferior with regard to pain control to controlled-release oxycodone taken twice daily
Amendment
Amendment was made to the duration of the study from duration of 24 weeks to 52 weeks in order to collect long-term safety and efficacy data OROS hydromorphone 8 16 or 32 mg tablets QD or SR oxycodone 10 20 or 40 mg tablets BID Individual adjustments in dosing performed to achieve satisfactory pain control over 24 weeks Amendment treatment duration was extended to 52 weeks
Amendment
Amendment was made to the duration of the study from duration of 24 weeks to 52 weeks in order to collect long-term safety and efficacy data OROS hydromorphone 8 16 or 32 mg tablets QD or SR oxycodone 10 20 or 40 mg tablets BID Individual adjustments in dosing performed to achieve satisfactory pain control over 24 weeks Amendment treatment duration was extended to 52 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-005187-24 | EUDRACT_NUMBER | Janssen Pharmaceutica NV | None |
| OROS-ANA-3001 | OTHER | None | None |