INSOMNIAPhase 3EszoNCT01100164
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
A Phase 3 study testing Eszopiclone and Zopiclone in people with INSOMNIA, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- INSOMNIA
- What is being tested?
- Eszopiclone and Zopiclone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Apr 2012
- Phase
- Phase 3
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sign the informed consent form for the study;
- Be ≥ 20 to ≥ 64 years old;
- Have diagnosis of symptomatic primary insomnia for at least 3 months;
- Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
- Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).
Who cannot join
- Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
- Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
- Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
- Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
- History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
- History of substance abuse or dependence;
Show all 10Show fewer
- Patients with severe co-morbidities (at the investigator's opinion);
- Presence of liver disorders, cirrhosis or liver failure;
- Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
- Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.
Read the detailed description
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography.
The secondary objectives and endpoints of this study are as follows:
- To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:
- Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:
- Latency time to the beginning of the sleep;
- Frequency of night wake-ups;
- Time awake during bedtime;
- Early morning awakening;
- Total time in bed;
- Sleep efficiency;
- Sleep variables measured by actigraph;
- Insomnia Severity Index (see Appendix B);45
- Pittsburgh Sleep Quality Index (see Appendix C);46
- To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.
- Conditions
- INSOMNIA
- Being tested
- Eszopiclone, Zopiclone
- Keywords
- INSOMNIA, FOR THE TREATMENT OF 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.
EszopicloneDrug
Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
ZopicloneDrug
Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
| Study group | Role | What they receive |
|---|---|---|
| eszopiclone 3 mg | Experimental | Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) Receives: Drug: Eszopiclone |
| zopiclone 7,5mg | Active comparator | Zopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) Receives: Drug: Zopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to persistent sleep measured by polysomnography
Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography
Measured: 4 weeks
Secondary outcomes (1)
Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100164
- Sponsor's protocol ID
- EF097
- Acronym
- Eszo
- Status last verified
- Mar 2010
- First submitted
- 5 Apr 2010
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pinto LR Jr, Bittencourt LR, Treptow EC, Braga LR, Tufik S. Eszopiclone versus zopiclone in the treatment of insomnia. Clinics (Sao Paulo). 2016 Jan;71(1):5-9. doi: 10.6061/clinics/2016(01)02.
PubMed 26872077
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT01100164
- Acronym / sponsor ID
- Eszo / EF097
- Conditions
- INSOMNIA
- Keywords
- INSOMNIA, FOR THE TREATMENT OF INSOMNIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Apr 2010 (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 primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.
Detailed description
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography.
The secondary objectives and endpoints of this study are as follows:
- To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:
- Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:
- Latency time to the beginning of the sleep;
- Frequency of night wake-ups;
- Time awake during bedtime;
- Early morning awakening;
- Total time in bed;
- Sleep efficiency;
- Sleep variables measured by actigraph;
- Insomnia Severity Index (see Appendix B);45
- Pittsburgh Sleep Quality Index (see Appendix C);46
- To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eszopiclone 3 mg | Experimental | Drug: EszopicloneEszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) |
| zopiclone 7,5mg | Active comparator | Drug: ZopicloneZopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign the informed consent form for the study;
- Be ≥ 20 to ≥ 64 years old;
- Have diagnosis of symptomatic primary insomnia for at least 3 months;
- Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
- Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).
Key exclusion criteria (10 listed)
- Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
- Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
- Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
- Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
- History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
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 |
|---|---|---|
| EszopicloneEszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) | Drug | eszopiclone 3 mg |
| ZopicloneZopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) | Drug | zopiclone 7,5mg |
Primary outcome
Latency to persistent sleep measured by polysomnography
Time frame: 4 weeks
Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography
1 secondary outcome
Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency
Time frame: 6 weeks
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 27 Jul 2015.
- Derived from this study: PubMed 26872077Pinto LR Jr, Bittencourt LR, Treptow EC, Braga LR, Tufik S. Eszopiclone versus zopiclone in the treatment of insomnia. Clinics (Sao Paulo). 2016 Jan;71(1):5-9. doi: 10.6061/clinics/2016(01)02.
Related trials for INSOMNIA
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
Enrolling by invitation
Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
Insomnia, Depression
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eszopiclone and Zopiclone in people with INSOMNIA, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 10 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Latency to persistent sleep measured by polysomnography (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100164, which also lists 1 linked publication.
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 27 Jul 2015.