Chronic InsomniaPhase 4NCT00337272
Treating Chronic Insomnia in Breast Cancer Patients
A Phase 4 study testing Ramelteon in people with Chronic Insomnia, run by Accelerated Community Oncology Research Network at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Ramelteon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2006to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Augusta Oncology Associates, PC
Augusta, Georgia, 30901
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Tri-County Hematology & Oncology Associates
Canton, Ohio, 44718
Cancer Specialists of Tidewater, Ltd.
Chesapeake, Virginia, 23320
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Wilshire Oncology Medical Group, Inc.
La Verne, California, 91750
The West Clinic
Memphis, Tennessee, 38120
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Pottsville Cancer Center
Pottsville, Pennsylvania, 17901
About this study
Official title: Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
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.
Read the detailed description
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
- Chronic Insomnia
- Being tested
- Placebo, Ramelteon
- Keywords
- chronic insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo taken 30 minutes before bedtime days 1-28 of treatment period
RamelteonDrug
Also called Rozerem
8 mgs daily for days 1-28 of treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 (Placebo) | Placebo comparator | Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period. Receives: Drug: Placebo |
| 2 (Ramelteon) | Active comparator | Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. Receives: Drug: Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
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).
Measured: Every morning during the screening, treatment, and withdrawal periods
Secondary outcomes (7)
Quantitative Sleep Parameters - Total Sleep Time
The subject reports how many hours of sleep she got.
Measured: Every morning during the screening, treatment, and withdrawal periods
Quantitative Sleep Parameters - Number of Awakenings
The subject reports how many times she woke up during the night.
Measured: Every morning during the screening, treatment, and withdrawal periods
Qualitative Evaluation of Sleep - Global Sleep Impression
The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?" with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement.
Measured: Once during the withdrawal period
Qualitative Evaluation of Sleep - Quality of Sleep
The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.
Measured: Every morning during the screening, treatment, and withdrawal periods
Daytime Function - Fatigue
The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.
Measured: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Daytime Function - Despair
The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.
Measured: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Daytime Function - Distress
The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.
Measured: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionJan 2009
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerated Community Oncology Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Edward J. Stepanski, Ph.D., Study chair, Accelerated Community Oncology Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337272
- Sponsor's protocol ID
- ACORN AEJSINS0601
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2006
- Last updated
- 22 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
- ClinicalTrials.gov ID
- NCT00337272
- Acronym / sponsor ID
- ACORN AEJSINS0601
- Conditions
- Chronic Insomnia
- Keywords
- chronic insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Accelerated Community Oncology Research NetworkUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Jun 2006 (estimated)
- Results
- Posted 21 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Placebo) | Placebo comparator | Drug: PlaceboPatients will take placebo 30 minutes before bedtime days 1-28 of treatment period. |
| 2 (Ramelteon) | Active comparator | Drug: RamelteonPatients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo taken 30 minutes before bedtime days 1-28 of treatment period | Drug | 1 (Placebo) |
| RamelteonAlso: Rozerem8 mgs daily for days 1-28 of treatment period | Drug | 2 (Ramelteon) |
Primary outcome
Sleep Efficiency
Time frame: Every morning during the screening, treatment, and withdrawal periods
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).
7 secondary outcomes
Quantitative Sleep Parameters - Total Sleep Time
Time frame: Every morning during the screening, treatment, and withdrawal periods
Quantitative Sleep Parameters - Number of Awakenings
Time frame: Every morning during the screening, treatment, and withdrawal periods
Qualitative Evaluation of Sleep - Global Sleep Impression
Time frame: Once during the withdrawal period
Qualitative Evaluation of Sleep - Quality of Sleep
Time frame: Every morning during the screening, treatment, and withdrawal periods
Daytime Function - Fatigue
Time frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Daytime Function - Despair
Time frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Daytime Function - Distress
Time frame: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward J. Stepanski, Ph.D. study chair
Accelerated Community Oncology Research Network
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Chronic Insomnia, run by Accelerated Community Oncology Research Network at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Every morning during the screening, treatment, and withdrawal periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.