- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885141
Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder. (ZOLP_18_01)
July 24, 2020 updated by: Biolab Sanus Farmaceutica
Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®.
Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
Study Overview
Detailed Description
Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia.
Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia.
Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®.
Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.
Study Type
Interventional
Enrollment (Anticipated)
366
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luciano R Pinto Junior, PhD
- Phone Number: 55.11.973342037
- Email: lucianoribeiro48@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women ≥ 18 years and ≤ 64 years of age
- Participants willing and able to provide a written informed consent form, after an explanation of the nature of the study, and prior to any procedures related to the study.
- Adults with clinical diagnosis of insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V-TR) and who complain of difficulty in maintaining sleep, starting more than three months before the study initiation, and for three or more sleepless nights per week.
- Participants with ability to understand and willingness to comply with the study procedures
Exclusion Criteria:
- History of Allergy or Hypersensitivity to Zolpidem;
- All initial and secondary insomnia;
- Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.
- Participants who used central nervous system medication or other medication known to interfere with the sleep / wake up cycle within 15 days prior to enrollment in the study, at the discretion of the study investigator.
- Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.
- History of chemical dependence or alcohol abuse.
- Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.
- Participants who received any investigational medication in the last 12 months prior to study inclusion.
- Women who are pregnant or breastfeeding or who wish to become pregnant or who refuse to use safe contraceptive methods during the study.
- Any disorder of the circadian cycle.
- Regular night shift work within the last 2 weeks prior to study enrollment or expected to work in shifts during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Men - Placebo
Men - Placebo, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
EXPERIMENTAL: Men - Zolpidem 1.75 mg
Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
EXPERIMENTAL: Men - Zolpidem 3.5 mg
Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
PLACEBO_COMPARATOR: Women - Placebo
Women - Placebo, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
EXPERIMENTAL: Women - Zolpidem 1.0 mg
Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
EXPERIMENTAL: Women - Zolpidem 1.75 mg
Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
|
Zolpidem or Placebo if there is a wake up during the night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
Time Frame: 28 days
|
To analyse the efficacy of Zolpidem® Orodispersible treatment 1.0 mg or 1.75 mg in women and 1.75 mg and 3.5 mg in men, compared to placebo, after taking the medication when a spontaneous wake up occurs during 28 days.
The assessement will be performed by means of the standard questionnaire before and at the end of the treatment period.
The computed mean difference for each treatment will be compared by ANOVA (treatment doses vs placebo in each gender) in order to assess its statistical significance.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Sleep Time (polysomnography parameter)
Time Frame: 1 day
|
Total Sleep Time after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
|
1 day
|
Sleep Efficiency (polysomnography parameter)
Time Frame: 1 day
|
Sleep Efficiency after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
|
1 day
|
Sleep Latency (polysomnography parameter)
Time Frame: 1 day
|
Sleep Latency after a provoked wake up, and the administration of 1 tablet of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and 1.75 mg or 3.5 mg in men, as compared to placebo administration after a provoked wake up.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 1, 2021
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
December 1, 2021
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 20, 2019
First Posted (ACTUAL)
March 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- ZOLP_18_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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