Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003686
Status:
TERMINATED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
Status:
TERMINATED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy It is not yet known whether pilocarpine is more effective than no further treatment for this condition
PURPOSE Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids
PURPOSE Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids
Detailed Description:
OBJECTIVES I Evaluate the effectiveness of daily oral pilocarpine versus placebo in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks by comparing proportion of patients with at least one response during the 2 week period time of first response and duration of first response II Evaluate the adverse effects of pilocarpine in these patients III Evaluate whether constipation sedation poor appetite and nausea are ameliorated by pilocarpine in these patients IV Evaluate the effect of pilocarpine on quality of life of this patient group V Determine the timing and duration of the effect of pilocarpine in this patient population
OUTLINE This is a randomized double-blind multicenter study Patients receive either oral pilocarpine four times daily arm I or oral placebo four times daily arm II for 4 weeks At the end of the 4 weeks all patients are given the option to receive oral pilocarpine Quality of life is assessed 2 days prior to randomization after 2 weeks of treatment and after 4 weeks of treatment
PROJECTED ACCRUAL There will be 60 patients accrued into this study within 18 months
OUTLINE This is a randomized double-blind multicenter study Patients receive either oral pilocarpine four times daily arm I or oral placebo four times daily arm II for 4 weeks At the end of the 4 weeks all patients are given the option to receive oral pilocarpine Quality of life is assessed 2 days prior to randomization after 2 weeks of treatment and after 4 weeks of treatment
PROJECTED ACCRUAL There will be 60 patients accrued into this study within 18 months
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 |
|---|---|---|---|
| CDR0000066788 | OTHER | PDQ unique registration number | None |
| CAN-NCIC-SC16 | OTHER | None | None |
| P-UPJOHN-CAN-NCIC-SC16 | OTHER | None | None |