Study of the Insomnia in Patients With Low Back Pain

NCT00365976 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-07-24

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone.

Conditions

  • Primary Insomnia

Interventions

DRUG

Eszopiclone

Eszopiclone 3 mg po nightly for duration of study blind phase.

DRUG

Placebo

Placebo nightly over duration of double blind study phase

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    collaborator INDUSTRY
  • Duke University

    lead OTHER

Principal Investigators

  • Andrew D Krystal, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00365976 on ClinicalTrials.gov