Pharmacological Treatment of Insomnia in Palliative Care
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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.
Condition or disease
Drug: ZopicloneDrug: Placebo
The clinical trial is a randomized, double-blind, placebo controlled, parallel-group, multicenter trial investigating the short time effectiveness of zopiclone on self-reported sleep quality in patients with advanced cancer who use opioids and who report insomnia. Patients with advanced cancer who use opioids and who report insomnia are randomized to either a hypnotic, zopiclone (Arm A) or placebo (Arm B) for six nights. For this study zopiclone Actavis 3.75 mg, 5 mg and 7.5 mg (active comparator) and placebo are defined as Investigational Medicinal Products. The initial dose is zopiclone/placebo 3.75 mg/day. Evaluation of sleep quality is performed in the morning after night 2 and 4 with evaluation of sleep quality by using a numerical rating scale 0-10 with the question "Please circle the number that best describes how you feel now" 0= Best sleep, 10= Worst possible sleep.
Pharmacological Treatment of Insomnia in Palliative Care: A Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial Investigating the Short Time Effect of Zopiclone on Self-reported Sleep Quality in Patients With Advanced Cancer Who Use Opioids and Who Report Insomnia
Actual Study Start Date :
November 15, 2016
Estimated Primary Completion Date :
December 15, 2020
Estimated Study Completion Date :
December 15, 2020
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically verified malignant disease
Presence of metastatic / disseminated disease
Presence of insomnia syndrome defined as:
Self-reported difficulty with initiating sleep (greater than 30 minutes to sleep onset) and/or difficulty maintaining sleep (greater than 30 minutes nocturnal waking time); and
Sleep difficulty at least 3 nights per week; and
Sleep difficulty that causes significant impairment of daytime functioning (The patient will be asked if sleep difficulty result in altered daytime function i.e. feeling tired, lack of energy)
Able to comply with all study procedures
Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
On-going treatment or previous treatment (within last 4 weeks) for more than consecutive 3 days with medications given for insomnia
Adverse reactions to zopiclone
History of substance abuse
Concomitant use of rifampicin and erythromycin
Any other contraindication listed on the summary of product characteristics of the investigated medicinal product:
An established diagnosis of Severe impairment of respiratory function
An established diagnosis of Severe hepatic insufficiency.(Child-Pugh grade B or C)
An established diagnosis of sleep apnea
Known hypersensitivity to the drug or to any component in its formulation: Lactose monohydrate, Calcium hydrogen phosphate, Maize starch, Croscarmellose sodium, Magnesium stearate, Titanium dioxide (E 171), Hypromellose, Iron oxide yellow/Iron oxide red (E 172) and Macrogol
Unfit for participation for any reason as judged by the investigator
Pregnancy or lactation
Women of reproductive age not willing or unable to employ an effective method of contraception (sterilization, using IUD or oral contraception)
Scheduled surgery within the next week
In the need of change in scheduled opioid dose at baseline (study visit 1)
Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week
Change in corticosteroid dose last week before baseline or planned dose change in corticosteroid dose within 7 days from baseline