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Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men

NCT02599701 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-07-13

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men.

Conditions

  • Sleep

Interventions

DRUG

Gabapentin

A single dose Gabapentin 300mg at bedtime.

DRUG

Placebo

A single placebo dose with the same physical characteristics of the active intervention.

Sponsors & Collaborators

  • Associação Fundo de Incentivo à Pesquisa

    lead OTHER

Principal Investigators

  • Sergio Tufik, PhD · AFIP - Associação Fundo de Incentivo a Pesquisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599701 on ClinicalTrials.gov