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Pharmacological Treatment of Insomnia in Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02807922
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : January 4, 2019
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Insomnia Drug: Zopiclone Drug: Placebo Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: Zopiclone
Zopiclone six nights
Drug: Zopiclone
Placebo Comparator: Placebo
Placebo six nights
Drug: Placebo

Primary Outcome Measures :
  1. Patient-reported sleep quality [ Time Frame: Night six (last study night) ]
    Primary endpoint is patient-reported sleep quality during the final study night (night six) assessed on a numerical rating scale (NRS) 0-10. 0= Best sleep, 10=Worst possible sleep.

Secondary Outcome Measures :
  1. Patient reported total sleep time [ Time Frame: Night six (last study night) ]
  2. Patient reported sleep onset latency [ Time Frame: Night six (last study night) ]
    Sleep onset latency (how long (minutes) it takes to fall asleep

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically verified malignant disease
  2. Presence of metastatic / disseminated disease
  3. Presence of insomnia syndrome defined as:

    1. 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
    2. Sleep difficulty at least 3 nights per week; and
    3. 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)
  4. Able to comply with all study procedures
  5. 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.

Exclusion Criteria:

  1. On-going treatment or previous treatment (within last 4 weeks) for more than consecutive 3 days with medications given for insomnia
  2. Adverse reactions to zopiclone
  3. History of substance abuse
  4. Concomitant use of rifampicin and erythromycin
  5. Any other contraindication listed on the summary of product characteristics of the investigated medicinal product:

    1. Myasthenia gravis
    2. An established diagnosis of Severe impairment of respiratory function
    3. An established diagnosis of Severe hepatic insufficiency.(Child-Pugh grade B or C)
    4. An established diagnosis of sleep apnea
    5. 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
  6. Unfit for participation for any reason as judged by the investigator
  7. Pregnancy or lactation
  8. Women of reproductive age not willing or unable to employ an effective method of contraception (sterilization, using IUD or oral contraception)
  9. Scheduled surgery within the next week
  10. In the need of change in scheduled opioid dose at baseline (study visit 1)
  11. Scheduled intravenous administration of chemotherapy during the study period (from baseline to day 8) or intravenous administration of chemotherapy during the last week
  12. Change in corticosteroid dose last week before baseline or planned dose change in corticosteroid dose within 7 days from baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02807922

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Contact: Pål Klepstad
Contact: Gunnhild Jakobsen

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Sunniva senter for lindrende behandling, Haraldsplass Diakonale sykehus Recruiting
Bergen, Norway, 5892
Contact: Katrin Sigurdardottir         
Sub-Investigator: Katrin Sigurdardottir, MD         
sykehuset Levanger Recruiting
Levanger, Norway, 7601
Contact: Ganna Westvik         
Sub-Investigator: Ganna Westvik, MD         
Helse Sør-Øst RHF, Sykehuset i Telemark, Recruiting
Skien, Norway, 3710
Contact: Ørnulf Paulsen         
Sub-Investigator: Ørnulf Paulsen, MD         
St. Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Pål Klepstad   
Contact: Gunnhild Jakobsen   
Principal Investigator: Pål Klepstad, MD         
Sub-Investigator: Morten Thronæs, MD         
Sub-Investigator: Sunil X Raj, MD         
Helse Sør-Øst RHF, Sykehuset i Vestfold, Recruiting
Tønsberg, Norway, 3103
Contact: Ole Kristian Andersen         
Contact: Nina Firing         
Sub-Investigator: Ole K Andersen, MD         
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
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Principal Investigator: Pål Klepstad St. Olavs Hospital

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Responsible Party: St. Olavs Hospital Identifier: NCT02807922     History of Changes
Other Study ID Numbers: SleepRCT_270215
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Palliative Care
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs