Sleep Initiation and Maintenance DisordersPhase 3NCT02183233
Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
A Phase 3 study testing Eschscholtzia Californica in people with Sleep Initiation and Maintenance Disorders, run by Boehringer Ingelheim.
Trial summary
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Eschscholtzia Californica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Jun 1998
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female above 18 or below 65 years old
- Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
- Written informed consent
Who cannot join
- Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months
- Patient who has an history of psychiatric diseases, such as:
- anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be < 10
- depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be < 10
- mania
- schizophrenia
Show all 22Show fewer
- dementia
- Patient who has an history of neurologic diseases, such as:
- Parkinson syndrome
- crania cerebral trauma post syndrome
- brain tumor
- fibromyalgia
- Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
- Patient with an hypersomnia or a sleep apnea syndrome
- Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea
- Patient with a Restless Leg Syndrome
- Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial
- Breast feeding or pregnant female, or female with no efficient contraception method
- Patient with non-stabilised thyroid dysfunction
- Patient with a known allergy to Eschscholtzia Californica or its compounds
- Patient with alcohol or drug dependency
- Patient drinking tea, coffee or Coca-Cola after 4 p.m.
About this study
Official title: A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.
- Being tested
- Eschscholtzia Californica, Eschscholtzia Californica Placebo
- 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.
Eschscholtzia CalifornicaDrug
Eschscholtzia Californica PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Eschscholtzia Californica | Experimental | Not described Receives: Drug: Eschscholtzia Californica |
| Eschscholtzia Californica Placebo | Placebo comparator | Not described Receives: Drug: Eschscholtzia Californica Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sleep latency
Measured: Days 0, 7, 14 and 28
Secondary outcomes (8)
Change from baseline in sleep duration
Measured: Days 0, 7, 14 and 28
Change from baseline in number of awakenings
Measured: Days 0, 7, 14 and 28
Change from baseline in quality of sleep
Measured: Days 0, 7, 14 and 28
Change from baseline in presence of morning sleepiness
Measured: Days 0, 7, 14 and 28
Change from baseline in morning concentration ability
Measured: Days 0, 7, 14 and 28
Change from baseline in Clinical Global Impression (CGI) score
Measured: Days 0, 7, 14 and 28
Change from baseline in quality of life (QL questionnaire SF-23)
Measured: Days 0, 7, 14 and 28
Number of patients with adverse events
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJan 1998
- Primary completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183233
- Sponsor's protocol ID
- 1120.2
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.
- ClinicalTrials.gov ID
- NCT02183233
- Acronym / sponsor ID
- 1120.2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1998
- Primary completion
- Jun 1998 (actual)
- First posted
- 8 Jul 2014 (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 aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eschscholtzia Californica | Experimental | Drug: Eschscholtzia Californica |
| Eschscholtzia Californica Placebo | Placebo comparator | Drug: Eschscholtzia Californica Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female above 18 or below 65 years old
- Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
- Written informed consent
Key exclusion criteria (22 listed)
- Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months
- Patient who has an history of psychiatric diseases, such as:
- Patient who has an history of neurologic diseases, such as:
- Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic
- Patient with an hypersomnia or a sleep apnea syndrome
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 |
|---|---|---|
| Eschscholtzia Californica | Drug | Eschscholtzia Californica |
| Eschscholtzia Californica Placebo | Drug | Eschscholtzia Californica Placebo |
Primary outcome
Change from baseline in sleep latency
Time frame: Days 0, 7, 14 and 28
8 secondary outcomes
Change from baseline in sleep duration
Time frame: Days 0, 7, 14 and 28
Change from baseline in number of awakenings
Time frame: Days 0, 7, 14 and 28
Change from baseline in quality of sleep
Time frame: Days 0, 7, 14 and 28
Change from baseline in presence of morning sleepiness
Time frame: Days 0, 7, 14 and 28
Change from baseline in morning concentration ability
Time frame: Days 0, 7, 14 and 28
Change from baseline in Clinical Global Impression (CGI) score
Time frame: Days 0, 7, 14 and 28
Change from baseline in quality of life (QL questionnaire SF-23)
Time frame: Days 0, 7, 14 and 28
Number of patients with adverse events
Time frame: up to 28 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eschscholtzia Californica in people with Sleep Initiation and Maintenance Disorders, run by Boehringer Ingelheim.
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 3 inclusion and 22 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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 was stopped early. Results are not available in the source record.
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?
Change from baseline in sleep latency (time frame: Days 0, 7, 14 and 28). 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 8 Jul 2014.