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Treating Chronic Insomnia in Breast Cancer Patients

NCT00337272 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-08-22

Study results available
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Summary

This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Conditions

  • Chronic Insomnia

Interventions

DRUG

Placebo

Placebo taken 30 minutes before bedtime days 1-28 of treatment period

DRUG

Ramelteon

8 mgs daily for days 1-28 of treatment period

Sponsors & Collaborators

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Edward J. Stepanski, Ph.D. · Accelerated Community Oncology Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-08-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337272 on ClinicalTrials.gov