Phase 4
Completed N=45
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00365261 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Pain — 3.72; 5.41 scores on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
3.72; 5.41 | — |
| PRIMARY Patient Self-report Data on Fatigue |
2.41; 2.77 | — |
| SECONDARY Opiate Dosing From Patient Controlled Analgesia |
36.35; 40.94 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00365261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.