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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

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date March 21, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Insomnia Disorder
Intervention  ICMJE Drug: Zolpidem
Zolpidem or Placebo if there is a wake up during the night
Study Arms  ICMJE
  • Placebo Comparator: Men - Placebo
    Men - Placebo, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
  • Experimental: Men - Zolpidem 1.75 mg
    Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
  • Experimental: Men - Zolpidem 3.5 mg
    Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
  • Placebo Comparator: Women - Placebo
    Women - Placebo, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
  • Experimental: Women - Zolpidem 1.0 mg
    Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
  • Experimental: Women - Zolpidem 1.75 mg
    Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs
    Intervention: Drug: Zolpidem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
366
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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

Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luciano R Pinto Junior, PhD 55.11.973342037 lucianoribeiro48@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885141
Other Study ID Numbers  ICMJE ZOLP_18_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Biolab Sanus Farmaceutica
Study Sponsor  ICMJE Biolab Sanus Farmaceutica
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biolab Sanus Farmaceutica
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP