SleepPhase 4NCT02807922
Pharmacological Treatment of Insomnia in Palliative Care
A Phase 4 study testing Zopiclone in people with Sleep and Insomnia, run by St. Olavs Hospital at 5 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Zopiclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesNorway
- Study dates
- 15 Nov 2016to 13 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Myasthenia gravis
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Sunniva senter for lindrende behandling, Haraldsplass Diakonale sykehus
Bergen, 5892
sykehuset Levanger
Levanger, 7601
Helse Sør-Øst RHF, Sykehuset i Telemark,
Skien, 3710
Helse Sør-Øst RHF, Sykehuset i Vestfold,
Tønsberg, 3103
St. Olavs Hospital
Trondheim, 7006
About this study
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
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.
Read the 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.
- Being tested
- Zopiclone, Placebo
- Keywords
- Palliative Care, zopiclone
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZopicloneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Zopiclone | Active comparator | Zopiclone six nights Receives: Drug: Zopiclone |
| Placebo | Placebo comparator | Placebo six nights Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported sleep quality
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.
Measured: Night six (last study night)
Secondary outcomes (2)
Patient reported total sleep time
Measured: Night six (last study night)
Patient reported sleep onset latency
Sleep onset latency (how long (minutes) it takes to fall asleep
Measured: Night six (last study night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start15 Nov 2016
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Pål Klepstad, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807922
- Sponsor's protocol ID
- SleepRCT_270215
- Other IDs
- 2015-005306-11, 2015
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2016
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30591073Jakobsen 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.
PubMed 36534165
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02807922
- Acronym / sponsor ID
- SleepRCT_270215
- Keywords
- Palliative Care, zopiclone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zopiclone | Active comparator | Drug: ZopicloneZopiclone six nights |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo six nights |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically verified malignant disease
- Presence of metastatic / disseminated disease
- Presence of insomnia syndrome defined as:
- 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.
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zopiclone | Drug | Zopiclone |
| Placebo | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Patient reported total sleep time
Time frame: Night six (last study night)
Patient reported sleep onset latency
Time frame: Night six (last study night)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 30591073Jakobsen 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.
- Derived from this study: PubMed 36534165Jakobsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Klepstad principal investigator
St. Olavs Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zopiclone in people with Sleep and Insomnia, run by St. Olavs Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported sleep quality (time frame: Night six (last study night)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807922, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.