|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Daiichi Sankyo Inc. |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017511 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cancer-Related Problem/Condition Head and Neck Cancer |
Drug: cevimeline hydrochloride |
Phase III |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders Tonsils and Adenoids |
| Drug Information available for: | Salicylsalicylic acid Sodium salicylate AF 102B Cevimeline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| 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 |
| Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 280 patients (140 per arm) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Received more than 4,000 cGy of prior external beam radiotherapy for cancer in the head and neck region
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 71 Study Locations |
| Daiichi Sankyo Inc. |
| Study Chair: | Robert Vitti, MD | Daiichi Sankyo Inc. |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068698, DAIICHI-2011A-PRT003/004, UCLA-0104045 |
| First Received: | June 6, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017511 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|