Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-03-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Duble-blind and double-dummy

Study Groups

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HIPNOS 3

The study is double-dummy. Thus, the patient will take 2 tablets, as follow:

1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.

Group Type EXPERIMENTAL

Hipnos 3

Intervention Type DRUG

1 tablet, oral, once a day.

Hipnos 5 Placebo

Intervention Type OTHER

1 tablet, oral, once a day.

HIPNOS 5

The study is double-dummy. Thus, the patient will take 2 tablets, as follow:

1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.

Group Type EXPERIMENTAL

Hipnos 5

Intervention Type DRUG

1 tablet, oral, once a day.

Hipnos 3 Placebo

Intervention Type OTHER

1 tablet, oral, once a day.

HIPNOS Placebo

The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.

Group Type PLACEBO_COMPARATOR

Hipnos 5 Placebo

Intervention Type OTHER

1 tablet, oral, once a day.

Hipnos 3 Placebo

Intervention Type OTHER

1 tablet, oral, once a day.

Interventions

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Hipnos 3

1 tablet, oral, once a day.

Intervention Type DRUG

Hipnos 5

1 tablet, oral, once a day.

Intervention Type DRUG

Hipnos 5 Placebo

1 tablet, oral, once a day.

Intervention Type OTHER

Hipnos 3 Placebo

1 tablet, oral, once a day.

Intervention Type OTHER

Other Intervention Names

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EMS tablet EMS tablet Placebo Placebo

Eligibility Criteria

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Inclusion Criteria

* Participants aged 50 years or more;
* Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
* Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.

Exclusion Criteria

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
* History of hepatic impairment;
* Current smoking;
* Pregnancy or risk of pregnancy and lactating patients;
* History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
* Diagnosis of clinical diseases that interfere with sleep;
* Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
* Participation in clinical trial in the year prior to this study.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No