drugset / Trial / NCT02807922
Pharmacological Treatment of Insomnia in Palliative Care
Phase 4
Completed
43 enrolled
St. Olavs Hospital
Norwegian University of Science and Technology · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Sleep disturbance is frequent in patients with advanced cancer and decreases the tolerability of other symptoms and impairs quality of life. A detailed description of sleep disturbance and its association with other symptoms, and intervention studies on sleep medications are scarce in patients with advanced cancer. A well-designed randomized controlled trial is needed to determine the short time effectiveness of zopiclone on sleep quality, one of the currently available therapies of insomnia, and further to contribute to the clinical management of insomnia in patients with advanced cancer.
Timeline
- Start
- 2016-11-15
- Primary completion
- 2021-07-13
- Completion
- 2021-07-13
Publications
- Background Jakobsen G, Engstrom M, Paulsen O, Sjue K, Raj SX, Thronaes M, Hjermstad MJ, Kaasa S, Fayers P, Klepstad P. Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial. Trials. 2018 Dec 27;19(1):707. doi: 10.1186/s13063-018-3088-3.
- Jakobsen G, Sjue K, Paulsen O, Kaasa S, Hjermstad MJ, Klepstad P. Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial. Support Care Cancer. 2022 Dec 19;31(1):60. doi: 10.1007/s00520-022-07537-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Zopiclone | Small molecule | 3.75 mg | — |
| Comparator | Zopiclone | Small molecule | 5 mg | — |
| Comparator | Zopiclone | Small molecule | 7.5 mg | — |