Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020618
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-07-11
Brief Title:
Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Randomized Multicenter Crossover Phase II Study to Compare Pain Relief Following Morphine Administration Via AERxPMS vs Orally in Cancer Patients Experiencing Opioid-Sensitive Breakthrough Pain
Status:
COMPLETED
Status Verified Date:
2002-02
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:
RATIONALE Morphine that is inhaled may be more rapidly absorbed than morphine that is given by mouth It is not yet known if inhaled morphine is more effective than morphine given by mouth in relieving breakthrough pain
PURPOSE Randomized phase II trial to compare the effectiveness of inhaled morphine with that of morphine given by mouth in treating cancer patients who have breakthrough pain
PURPOSE Randomized phase II trial to compare the effectiveness of inhaled morphine with that of morphine given by mouth in treating cancer patients who have breakthrough pain
Detailed Description:
OBJECTIVES I Compare the change in pain intensity during the 15 minutes immediately following aerosolized vs oral morphine sulfate in cancer patients with opioid-sensitive breakthrough pain II Compare preference for continued use of these regimens in these patients III Compare the pain relief in patients treated with these regimens IV Evaluate satisfaction of patients treated with these regimens
OUTLINE This is a randomized open-label crossover multicenter study Patients are randomized to 1 of 2 treatment arms Patients undergo titration of aerosolized morphine sulfate over days 1-7 to determine the optimal baseline and breakthrough dosage Arm I Patients receive aerosolized morphine sulfate as needed for breakthrough pain up to 4 inhalations every 15 minutes on days 8-14 Patients crossover to oral morphine sulfate as needed for breakthrough pain on days 15-21 Arm II Patients receive oral morphine sulfate as needed for breakthrough pain on days 8-14 Patients crossover to aerosolized morphine sulfate as needed for breakthrough pain up to 4 inhalations every 15 minutes on days 15-21 Patients may continue treatment with either oral or aerosolized morphine sulfate for an additional 60 days beginning on day 22 Quality of life is assessed weekly for 3 weeks Patients complete a pain management satisfaction survey at the end of each therapy crossover week
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
OUTLINE This is a randomized open-label crossover multicenter study Patients are randomized to 1 of 2 treatment arms Patients undergo titration of aerosolized morphine sulfate over days 1-7 to determine the optimal baseline and breakthrough dosage Arm I Patients receive aerosolized morphine sulfate as needed for breakthrough pain up to 4 inhalations every 15 minutes on days 8-14 Patients crossover to oral morphine sulfate as needed for breakthrough pain on days 15-21 Arm II Patients receive oral morphine sulfate as needed for breakthrough pain on days 8-14 Patients crossover to aerosolized morphine sulfate as needed for breakthrough pain up to 4 inhalations every 15 minutes on days 15-21 Patients may continue treatment with either oral or aerosolized morphine sulfate for an additional 60 days beginning on day 22 Quality of life is assessed weekly for 3 weeks Patients complete a pain management satisfaction survey at the end of each therapy crossover week
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
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 |
|---|---|---|---|
| BWH-2000-P-001516 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068672 | REGISTRY | None | None |
| ARADIGM-MOR-00-01 | None | None | None |