NCT00365261

Brief Summary

To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

  • improve sleep thereby decreasing need for opiates via PCA
  • improve sleep thereby decreasing pain by self report
  • improve sleep thereby decreasing fatigue by self report

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 29, 2011

Completed
Last Updated

July 11, 2016

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

August 15, 2006

Results QC Date

August 24, 2011

Last Update Submit

June 3, 2016

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

painfatiguesleepbone marrow transplantcancer

Outcome Measures

Primary Outcomes (2)

  • Pain

    Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").

    post dosing

  • Patient Self-report Data on Fatigue

    Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).

    2 days post treatment

Secondary Outcomes (1)

  • Opiate Dosing From Patient Controlled Analgesia

    2 days post dosing

Study Arms (2)

eszopiclone

ACTIVE COMPARATOR

active drug

Drug: Eszopiclone

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

EszopicloneDRUG

eszopiclone 2 to 3 mg po at bedtime

Also known as: Lunesta
eszopiclone
PlaceboDRUG

placebo 2 to 3 mg po at bedtime

placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.
  • Age 20 - 75
  • Not currently regularly taking any prescribed sleeping pill more often than 4x/week.
  • Can tolerate oral medication.

You may not qualify if:

  • Patients with a current history of substance abuse
  • Patients with a history of allergic response to Lunesta.
  • Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Thornton Hospital

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • Dimsdale JE, Ball ED, Carrier E, Wallace M, Holman P, Mulroney C, Shaikh F, Natarajan L. Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies. Support Care Cancer. 2011 Dec;19(12):2015-20. doi: 10.1007/s00520-010-1052-1. Epub 2010 Nov 30.

    PMID: 21116652RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPainFatigueNeoplasms

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPyridines

Results Point of Contact

Title
Joel Dimsdale, M.D., Principal Investigator
Organization
University of California, San Diego
jdimsdale@ucsd.edu
619 543-5592

Study Officials

  • Joel E Dimsdale, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 11, 2016

Results First Posted

September 29, 2011

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)