Obstructive Sleep Apnea SyndromePhase 2NCT00685269
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
A Phase 2 study testing Eszopiclone in people with Obstructive Sleep Apnea Syndrome, run by Sumitomo Pharma America, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Eszopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2003to Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
- Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
- Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
- Subjects must use continuous positive airway pressure (CPAP).
- Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).
Who cannot join
- Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
- Subject has a history of, or current malignancy except for non melanomatous skin cancer.
- Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
- Subject is known to be seropositive for human immunodeficiency virus (HIV).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Atlanta, Georgia
Study site
Cincinnati, Ohio
About this study
Official title: The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
Read the detailed description
Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Eszopiclone, Placebo
- Keywords
- Obstructive Sleep Apnea Syndrome, OSAS
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EszopicloneDrug
Also called Lunesta, (S)-Zopliclone
Eszopiclone 3 mg QD
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | eszopiclone 3 mg QD Receives: Drug: Eszopiclone |
| B | Placebo comparator | placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI (frequency of apnea and hypopnea episodes).
Measured: Nights -14, 1, 2, 8, 9
Secondary outcomes (4)
The mean duration of apnea and hypopnea episodes
Measured: Nights -14, 1, 2, 8, 9
Oxygen saturation during apnea and hypopnea
Measured: Nights -14, 1, 2, 8, 9
The number of arousals during apnea and hypopnea
Measured: Nights -14, 1, 2, 8, 9
Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset
Measured: Nights -14, 1, 2, 8, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startAug 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685269
- Sponsor's protocol ID
- 190-028
- Status last verified
- Feb 2012
- First submitted
- 23 May 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00685269
- Acronym / sponsor ID
- 190-028
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea Syndrome, OSAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
Detailed description
Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Eszopicloneeszopiclone 3 mg QD |
| B | Placebo comparator | Drug: Placeboplacebo tablet |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
- Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
- Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
- Subjects must use continuous positive airway pressure (CPAP).
- Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).
Key exclusion criteria (4 listed)
- Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
- Subject has a history of, or current malignancy except for non melanomatous skin cancer.
- Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
- Subject is known to be seropositive for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| EszopicloneAlso: Lunesta, (S)-ZoplicloneEszopiclone 3 mg QD | Drug | A |
| PlaceboPlacebo tablet | Drug | B |
Primary outcome
AHI (frequency of apnea and hypopnea episodes).
Time frame: Nights -14, 1, 2, 8, 9
4 secondary outcomes
The mean duration of apnea and hypopnea episodes
Time frame: Nights -14, 1, 2, 8, 9
Oxygen saturation during apnea and hypopnea
Time frame: Nights -14, 1, 2, 8, 9
The number of arousals during apnea and hypopnea
Time frame: Nights -14, 1, 2, 8, 9
Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset
Time frame: Nights -14, 1, 2, 8, 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eszopiclone in people with Obstructive Sleep Apnea Syndrome, run by Sumitomo Pharma America, Inc. at 2 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AHI (frequency of apnea and hypopnea episodes). (time frame: Nights -14, 1, 2, 8, 9). 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 Feb 2012.