Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003687
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Treatment for Chronic Pain in Patients With Advanced Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably It is not yet known which regimen is most effective for chronic pain
PURPOSE Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer
Detailed Description:
OBJECTIVES
Compare the analgesic efficacy of two formulations of morphine Statex SR versus MS-Contin in patients requiring morphine for the treatment of chronic cancer pain
Compare the effect of these 2 formulations of morphine on the total analgesic consumption sleep disturbances sleep and nausea responses of different types of pain and toxic effects experienced in the two treatment groups
Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups phase B
Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption sleep disturbances sleep and nausea responses of different types of pain and toxic effects on the two treatment groups phase B
OUTLINE This is a randomized double-blind parallel-group multicenter study Patients are stratified by stabilization dose less than 120 mgday vs greater than 120 mgday of morphine and institution in phase A and neuropathic pain yes vs no in phase B
Phase A Patients are randomized to receive oral morphine in one of two formulations MS Contin or Statex SR every 12 hours for 7 days
Phase B Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours and oral morphine tablets every 12 hours for 14 days
Phase C All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days
Patients complete a pain diary twice each day during treatment
Compare the analgesic efficacy of two formulations of morphine Statex SR versus MS-Contin in patients requiring morphine for the treatment of chronic cancer pain
Compare the effect of these 2 formulations of morphine on the total analgesic consumption sleep disturbances sleep and nausea responses of different types of pain and toxic effects experienced in the two treatment groups
Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups phase B
Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption sleep disturbances sleep and nausea responses of different types of pain and toxic effects on the two treatment groups phase B
OUTLINE This is a randomized double-blind parallel-group multicenter study Patients are stratified by stabilization dose less than 120 mgday vs greater than 120 mgday of morphine and institution in phase A and neuropathic pain yes vs no in phase B
Phase A Patients are randomized to receive oral morphine in one of two formulations MS Contin or Statex SR every 12 hours for 7 days
Phase B Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours and oral morphine tablets every 12 hours for 14 days
Phase C All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days
Patients complete a pain diary twice each day during treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000066789 | OTHER | PDQ | None |
| CAN-NCIC-SC17 | OTHER | None | None |