Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the
efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).
Every morning during the screening, treatment, and withdrawal periods
Edward J. Stepanski, Ph.D.
Accelerated Community Oncology Research Network
United States: Institutional Review Board
|North Idaho Cancer Center||Coeur d'Alene, Idaho 83814|
|Wilshire Oncology Medical Group, Inc.||Rancho Cucamonga, California 91730|
|Eastern Connecticut Hematology and Oncology Associates||Norwich, Connecticut 06360|
|Genesis Cancer Center||Hot Springs, Arkansas 71913|
|Hematology Oncology Centers of the Northern Rockies||Billings, Montana 59101|
|The West Clinic||Memphis, Tennessee 38120|
|Augusta Oncology Associates, PC||Augusta, Georgia 30901|
|Cancer Specialists of Tidewater, Ltd.||Chesapeake, Virginia 23320|
|Tri-County Hematology & Oncology Associates||Canton, Ohio 44718|
|Pottsville Cancer Center||Pottsville, Pennsylvania 17901|