Treating Chronic Insomnia in Breast Cancer Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1 (Placebo)

Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

2 (Ramelteon)

Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.

Group Type ACTIVE_COMPARATOR

Ramelteon

Intervention Type DRUG

8 mgs daily for days 1-28 of treatment period

Interventions

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Placebo

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

Intervention Type DRUG

Ramelteon

8 mgs daily for days 1-28 of treatment period

Intervention Type DRUG

Other Intervention Names

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Rozerem

Eligibility Criteria

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Inclusion Criteria

* Female patients aged 21-60 years old
* Have a negative serum or urine pregnancy test for women of child-bearing potential
* Have a three-month or longer history of insomnia
* Self-report \< 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
* A score of less than 60 on the Zung Self-Rating Depression Scale
* Self-report bedtimes that do not vary by more than two hours on five nights per week
* Have completed chemotherapy for breast cancer less than two years prior to study drug administration
* Have completed chemotherapy for breast cancer for at least two months prior to screening visit
* Patients that are receiving Herceptin are eligible for study enrollment
* Have completed radiation therapy for breast cancer for at least two months prior to screening visit
* ECOG (Eastern Cooperative Oncology Group)score of 0-1
* Be able to read, understand, and provide written informed consent before enrolling in the study
* Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
* Agree to participate for the entire study period (about two months)

Exclusion Criteria

* Metastatic disease
* Pregnant or lactating female
* Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
* Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
* Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
* Currently taking fluvoxamine, brand name Luvox
* Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
* Currently on night or rotating shift work
* Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
* Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
* A score of 60 or greater on the Zung Self-Rating Depression Scale
* Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No