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NCT02807922

Pharmacological Treatment of Insomnia in Palliative Care

Completed Phase 4 Last updated 16 July 2021
What this trial tests

Phase 4 trial testing Zopiclone in Sleep in 43 participants. Completed in 13 July 2021.

Timeline
15 November 2016
Primary endpoint
13 July 2021
13 July 2021

Quick facts

Lead sponsorSt. Olavs Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment43
Start date15 November 2016
Primary completion13 July 2021
Estimated completion13 July 2021
Sites5 locations across Norway

Drugs / interventions tested

Conditions studied

Sponsor

St. Olavs Hospital

Who can join

18 and older, any sex, with Sleep or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Jakobsen G, Sjue K, Paulsen Ø, Kaasa S, et al · · 2022 · cited 6× · PMID 36534165 · DOI 10.1007/s00520-022-07537-x
  2. 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.
    Jakobsen G, Engstrøm M, Paulsen Ø, Sjue K, et al · · 2018 · cited 3× · PMID 30591073 · DOI 10.1186/s13063-018-3088-3

Verify or expand the search:

Other trials of Zopiclone

Trials testing the same drug.

Other recruiting trials for Sleep

Currently open trials in the same condition.

Other St. Olavs Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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