Trial Outcomes & Findings for Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer (NCT NCT00365261)

NCT ID: NCT00365261

Last Updated: 2016-07-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 45 participants
• Primary outcome timeframe: post dosing
• Results posted on: 2016-07-11

Participant Flow

Participant milestones

Measure	Eszopiclone receipt of active drug	Placebo receipt of placebo
Overall Study STARTED	23	22
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Baseline characteristics by cohort

Measure	Eszopiclone n=23 Participants receipt of active drug	Placebo n=22 Participants receipt of placebo	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	45.52 years STANDARD_DEVIATION 13.06 • n=5 Participants	46 years STANDARD_DEVIATION 15.86 • n=7 Participants	45.76 years STANDARD_DEVIATION 14.33 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: post dosing

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

Outcome measures

Measure	Eszopiclone n=23 Participants active drug	Placebo n=22 Participants placebo
Pain	3.72 scores on a scale Standard Error 0.38	5.41 scores on a scale Standard Error 0.47

PRIMARY outcome

Timeframe: 2 days post treatment

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).

Outcome measures

Measure	Eszopiclone n=23 Participants active drug	Placebo n=22 Participants placebo
Patient Self-report Data on Fatigue	2.41 scores on a scale Standard Error 0.20	2.77 scores on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: 2 days post dosing

Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.

Outcome measures

Measure	Eszopiclone n=23 Participants active drug	Placebo n=22 Participants placebo
Opiate Dosing From Patient Controlled Analgesia	36.35 mg Interval 17.57 to 58.46	40.94 mg Interval 23.37 to 66.19

Adverse Events

Eszopiclone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Eszopiclone n=23 participants at risk receipt of active drug	Placebo n=22 participants at risk receipt of placebo
General disorders fatigue	13.0% 3/23 • Number of events 3	13.6% 3/22 • Number of events 3

Additional Information

Joel Dimsdale, M.D., Principal Investigator

University of California, San Diego

Phone: 619 543-5592

Email: jdimsdale@ucsd.edu

Results disclosure agreements

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