A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
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ClinicalTrials.gov Identifier: NCT00411034 |
Recruitment Status :
Completed
First Posted : December 13, 2006
Last Update Posted : April 27, 2010
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Sponsor:
Alza Corporation, DE, USA
Information provided by:
Alza Corporation, DE, USA
Tracking Information | ||||
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First Submitted Date ICMJE | December 12, 2006 | |||
First Posted Date ICMJE | December 13, 2006 | |||
Last Update Posted Date | April 27, 2010 | |||
Study Start Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain | |||
Official Title ICMJE | A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain | |||
Brief Summary | The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated. | |||
Detailed Description | This randomized (patients assigned to treatment by chance), single-blind (with respect to dose), open-label (patients know what study treatment, not dose, they are receiving) repeated dose study evaluating patients with chronic cancer pain was conducted in tandem (together) with a similar protocol in patients with chronic non-malignant pain. A total of 463 patients were enrolled and evaluated in these studies. Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone (slow release) using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone (slow release) was escalated after every 2 days of therapy until no more than 3 doses of immediate-release (IR) hydromorphone were required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS hydromorphone (slow release) for 3 consecutive days, the patient entered a 2-week maintenance phase. Patients who completed the study were eligible for participation in an OROS hydromorphone (slow release) long-term extension study, Study DO-109. The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence of side effects associated with peak (high) and trough (low) fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations. Patients received OROS Hydromorphone HCI (slow release) at Visit 2,3, and 4 (either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI (slow release) doses were titrated after every two days of therapy as necessary until dose stabilization occured, followed by a two week Maintenance Therapy Phase. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: OROS Hydromorphone HCI | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
463 | |||
Original Enrollment ICMJE |
300 | |||
Actual Study Completion Date ICMJE | September 1999 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00411034 | |||
Other Study ID Numbers ICMJE | CR011614 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Alza Corporation, DE, USA | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Alza Corporation, DE, USA | |||
Verification Date | April 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |