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Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder. (ZOLP_18_01)

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ClinicalTrials.gov Identifier: NCT03885141
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: Zolpidem Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assessment of the efficacy of Zolpidem treatment. The following will be evaluated: improvement of maintenance insomnia through the Sleep Diary and the Severity Index of the Insomnia (IGI), as well as sleep latency through polysomnography and treatment safety through the reporting of adverse events and laboratory tests.
Masking: Double (Participant, Investigator)
Masking Description: Placebo
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Men - Placebo
Men - Placebo, 1 tablet if a wake up occurs
Drug: Zolpidem
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
Drug: Zolpidem
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
Drug: Zolpidem
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
Drug: Zolpidem
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
Drug: Zolpidem
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
Drug: Zolpidem
Zolpidem or Placebo if there is a wake up during the night




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

Men: Placebo or Zolpidem 1.75 mg or Zolpidem 3.5 mg

Women: Placebo or Zolpidem 1.0 mg or Zolpidem 1.75 mg

Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women ≥ 18 years and ≤ 64 years of age
  2. 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.
  3. 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.
  4. Participants with ability to understand and willingness to comply with the study procedures

Exclusion Criteria:

  1. History of Allergy or Hypersensitivity to Zolpidem;
  2. All initial and secondary insomnia;
  3. Basal polysomnography with apnea and hypopnea index> 20 events / hour and PLM (Periodic Leg Movements)> 15 events / hour.
  4. 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.
  5. Clinically significant diseases or surgeries, at the discretion of the principal investigator, within 30 days prior to study inclusion.
  6. History of chemical dependence or alcohol abuse.
  7. Any significant neurological and psychiatric disease or laboratory findings present, unless adequately controlled with medication allowed in the protocol.
  8. Participants who received any investigational medication in the last 12 months prior to study inclusion.
  9. Women who are pregnant or breastfeeding or who wish to become pregnant or who refuse to use safe contraceptive methods during the study.
  10. Any disorder of the circadian cycle.
  11. Regular night shift work within the last 2 weeks prior to study enrollment or expected to work in shifts during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885141


Contacts
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Contact: Luciano R Pinto Junior, PhD 55.11.973342037 lucianoribeiro48@gmail.com

Sponsors and Collaborators
Biolab Sanus Farmaceutica

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Responsible Party: Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier: NCT03885141     History of Changes
Other Study ID Numbers: ZOLP_18_01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biolab Sanus Farmaceutica:
Insomnia
Zolpidem
Additional relevant MeSH terms:
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Zolpidem
GABA-A Receptor Agonists
GABA Agonists
Sleep Initiation and Maintenance Disorders
Disease
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action