Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

This study has been completed.

Study NCT00365261 Information provided by University of California, San Diego

First Received on August 15, 2006. Last Updated on August 24, 2011 History of Changes

Results First Received: August 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Sleep Initiation and Maintenance Disorders
Interventions:	Drug: Eszopiclone Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Eszopiclone	active drug
Placebo	placebo

Participant Flow: Overall Study

	Eszopiclone	Placebo
STARTED	23	22
COMPLETED	20	19
NOT COMPLETED	3	3

Baseline Characteristics

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Reporting Groups

	Description
Eszopiclone	active drug
Placebo	placebo

Baseline Measures

	Eszopiclone	Placebo	Total
Number of Participants [units: participants]	23	22	45
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	23	20	43
>=65 years	0	2	2
Age [units: years] Mean ± Standard Deviation	45.52 ± 13.06	46 ± 15.86	45.76 ± 14.33
Gender [units: participants]
Female	13	9	22
Male	10	13	23
Region of Enrollment [units: participants]
United States	23	22	45

Outcome Measures

1. Primary:

Pain [ Time Frame: post dosing ]

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2. Primary:

Patient Self-report Data on Sleep, Pain, and Fatigue [ Time Frame: 2 days post treatment ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Opiate Dosing From Patient Controlled Analgesia [ Time Frame: 2 days post dosing ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Joel Dimsdale, M.D., Principal Investigator
Organization: University of California, San Diego
phone: 619 543-5592
e-mail: jdimsdale@ucsd.edu

Publications of Results:

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. 2010 Nov 30; [Epub ahead of print]

Responsible Party:	Joel E. Dimsdale, M.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00365261 History of Changes
Other Study ID Numbers:	UCSD 060340, ESRC 054
Study First Received:	August 15, 2006
Results First Received:	August 24, 2011
Last Updated:	August 24, 2011
Health Authority:	United States: Institutional Review Board