Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017511
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2001-06-06
Brief Title:
Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase III Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Cevimeline in the Treatment of Xerostomia Secondary to Radiation Therapy for Cancer in the Head and Neck Region
Status:
COMPLETED
Status Verified Date:
2012-05
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:
RATIONALE Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of cevimeline vs placebo in terms of dryness of the oral cavity and salivary flow in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region
Assess the safety of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo as in arm I
PROJECTED ACCRUAL A total of 280 patients 140 per arm will be accrued for this study
Compare the efficacy of cevimeline vs placebo in terms of dryness of the oral cavity and salivary flow in patients with xerostomia secondary to radiotherapy for cancers in the head and neck region
Assess the safety of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral cevimeline 3 times daily for 12 weeks in the absence of unacceptable toxicity
Arm II Patients receive oral placebo as in arm I
PROJECTED ACCRUAL A total of 280 patients 140 per arm 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 |
|---|---|---|---|
| DAIICHI-2011A-PRT003004 | None | None | None |
| UCLA-0104045 | None | None | None |