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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)

Primary Purpose

Insomnia Disorder

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Zolpidem

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia, Zolpidem

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Men - Placebo

Men - Zolpidem 1.75 mg

Men - Zolpidem 3.5 mg

Women - Placebo

Women - Zolpidem 1.0 mg

Women - Zolpidem 1.75 mg

Arm Description

Men - Placebo, 1 tablet if a wake up occurs

Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs

Women - Placebo, 1 tablet if a wake up occurs

Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs

Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Outcomes

Primary Outcome Measures

Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment

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

Total Sleep Time (polysomnography parameter)

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)

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)

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.

Full Information

NCT ID

NCT03885141

First Posted

March 14, 2019

Last Updated

July 24, 2020

Sponsor

Biolab Sanus Farmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT03885141

Brief Title

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

Acronym

ZOLP_18_01

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 2021 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biolab Sanus Farmaceutica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia Disorder

Keywords

Insomnia, Zolpidem

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Masking Description

Placebo

Allocation

Randomized

Enrollment

366 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Men - Placebo

Arm Type

Placebo Comparator

Arm Description

Men - Placebo, 1 tablet if a wake up occurs

Arm Title

Men - Zolpidem 1.75 mg

Arm Type

Experimental

Arm Description

Men - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Arm Title

Men - Zolpidem 3.5 mg

Arm Type

Experimental

Arm Description

Men - Zolpidem 3.5 mg, 1 tablet if a wake up occurs

Arm Title

Women - Placebo

Arm Type

Placebo Comparator

Arm Description

Women - Placebo, 1 tablet if a wake up occurs

Arm Title

Women - Zolpidem 1.0 mg

Arm Type

Experimental

Arm Description

Women - Zolpidem 1.0 mg, 1 tablet if a wake up occurs

Arm Title

Women - Zolpidem 1.75 mg

Arm Type

Experimental

Arm Description

Women - Zolpidem 1.75 mg, 1 tablet if a wake up occurs

Intervention Type

Drug

Intervention Name(s)

Zolpidem

Intervention Description

Zolpidem or Placebo if there is a wake up during the night

Primary Outcome Measure Information:

Title

Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Total Sleep Time (polysomnography parameter)

Description

Time Frame

1 day

Title

Sleep Efficiency (polysomnography parameter)

Description

Time Frame

1 day

Title

Sleep Latency (polysomnography parameter)

Description

Time Frame

1 day

10. Eligibility

Sex

All

Gender Based

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

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luciano R Pinto Junior, PhD

Phone

55.11.973342037

lucianoribeiro48@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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