Trial Outcomes & Findings for Treatment of Insomnia and Glucose Metabolism (NCT NCT00724282)

NCT ID: NCT00724282

Last Updated: 2015-10-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: at the end of each treatment
• Results posted on: 2015-10-16

Participant Flow

Investigator left academia and is unavailable; participation in cross-over sequences was not unblinded, therefore participants are presented in one Arm throughout Results.

Participant milestones

Measure	Eszopiclone or Placebo Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Eszopiclone or Placebo Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

Treatment of Insomnia and Glucose Metabolism

Baseline characteristics by cohort

Measure	Eszopiclone or Placebo n=20 Participants Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: at the end of each treatment

Population: Investigator left university without analyzing data and no information is available on unblinding.

Outcome measures

Outcome data not reported

Adverse Events

Eszopiclone or Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Eszopiclone or Placebo n=20 participants at risk Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded. Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days Placebo: Placebo by mouth daily at bedtime for 9 days
Skin and subcutaneous tissue disorders Furuncle	5.0% 1/20

Additional Information

Andrea Eiring

University of Chicago

Phone: 773-702-3657

Email: aeiring@bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place