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A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia

NCT01277107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2014-12-19

No results posted yet for this study

Summary

This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.

Conditions

Interventions

DRUG

Zaleplon AP formulation

Gastric retentive dual release Zaleplon

DRUG

Placebo capsule

Identical placebo capsule

Sponsors & Collaborators

  • Intec Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT01277107 on ClinicalTrials.gov