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Sleep Initiation and Maintenance DisordersPhase 3NCT01450228

Efficacy and Safety of KI1001 in ≥ 55 Years Old Insomnia Patients

A Phase 3 study testing KI1001 in people with Sleep Initiation and Maintenance Disorders, run by Kuhnil Pharmaceutical Co., Ltd. at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
KI1001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
10 sitesSouth Korea
Study dates
Mar 2011to Mar 2012
Phase
Phase 3
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female and aged ≥55 years
  • Suffering from primary insomnia according to DSM-IV criteria and for whom this is the consultation complaint
  • Good anticipated compliance
  • Written informed consent to participate in the study given by the patient voluntarily
  • Confirmed diagnosis of primary insomnia by sleep history questionnaire
  • Established baseline pathology
  • A good compliance during the two-weeks placebo run-in period defined as 70% to 130% of prescribed tablets
  • Correct use of the Sleep Diary and of the LSEQ

Who cannot join

  • According to DSM-IV, subjects belonging to the following groups are excluded : 780.59(breathing related sleep disorder); 307.45(circadian thyrhm sleep disorder); 307.47(dyssomnia not otherwise specified); 780.XX(sleep disorder due to a general medical condition)
  • Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
  • Known positive serology for human immunodeficiency virus (HIV) I antibodies or HIV II antibodies
  • Known chronic active viral hepatitis
  • Drug abuse or history or drug abuse(including alcohol)
  • History of severe pathology likely to recur during or immediately after the study
Show all 29Show fewer
  • History of severe cardiac disorders
  • History of severe neurological disorders or cerebral neurosurgery
  • History of severe psychiatric disorders, especially psychosis and depression, sismotherapy
  • depression will be assessed by the Raskin scale : a patient with a total score ≥ 6 will not be included
  • anxiety will be assessed by the Covi scale : a patient with a total score ≥ 6 will not be included
  • dementia will be assessed with the Mini Mental State (MMS) : a patient with a score ≤ 24 or 26 (depending on the socio-educational level of the patient) will not be included
  • Neuro-psychiatric pathologies that might interfere with insomnia, patient assessment or study medication
  • Use of psychotropic treatments for the past 3 months and during the study
  • Use of benzodiazepines or other hypnotics during preceding two weeks (including all benzodiazepines; zopiclone, zolpidem, zaleplon, barbiturates, buspirone and hydroxyzine)
  • All hypnotics or treatments used as an hypnotic are not allowed during the study
  • Severe pain likely to interfere with sleep
  • Other sleep disorders according to DSM-IV criteria identified by numerical ICD 9 code: breathing-related sleep disorder (780.59), circadian rhythm sleep disorder (307.45), dyssomnia not otherwise specified (307.47) and other sleep disorders (780.xx)
  • Serious diseases that could interfere with patient assessment
  • Organic pathologies which have not stabilised and that might interfere with sleep, patient assessment or study medication
  • Intercurrent acute or chronic somatic diseases likely to interact with sleep (for example: chronic pain from any aetiology, benign prostatic hypertrophy likely to require surgery in the coming six months)
  • Any concomitant documented progressive disease likely to interfere with the conduct of the study
  • Any medical condition which might interfere with the completion of the study, or which would be adversely affected and thereby increasing the risk for the patient or interfering with patient assessments.
  • Patients with an excessive consumption of alcohol, coffee or tea
  • Patients with an irregular lifestyle or life pattern (e.g. shift workers and patients likely to be jet lagged)
  • Patients with a Body Mass Index above 30 - obesity
  • Patients who have taken any investigational drug within two months preceding the first dose of the study drug. Investigational drug is defined as any drug for which a marketing authorisation has not been granted in the country where the study was conducted.
  • Patients receiving concomitant treatment which are not permitted
  • A positive drug screen (benzodiazepines and opiates) during the initial two week placebo run-in period

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

South Korea10 sites

  • Dankook University Hospital

    Cheonan, Chungcheongnam, 330-715

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 200-722

  • Keimyung University, Dongsan Medical Center

    Daegu, Daegu, 700-712

  • Chonnam National University Hospital

    Gwangju, Gwangju, 501-757

  • St. Paul's Hospital

    Seoul, Seoul, 130-709

  • Kyung Hee University Hospital at Gangdong

    Seoul, Seoul, 134-727

  • Asan Medical Center

    Seoul, Seoul, 138-736

  • Konkuk University Medical Center

    Seoul, Seoul, 143-729

  • Seoul National University Bundang Hospital

    Sungnam, Gyeonggi-do, 463-707

  • St. Vincent Hospital

    Suwon, Gyeonggi-do, 442-723

Other trials in South Korea

About this study

Official title: A Double-blind, Parallel Group, Randomised, Placebo Controlled, Multicenter, Bridging Phase III Study of Efficacy and Safety of KI1001 in the Improvement of Sleep Quality in ≥ 55 Years Old Insomnia Patients

KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients. This is a bridging study to investigate the efficacy and safety of KI1001(Circadin®) in Korean patients.

Read the detailed description

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics.

However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day.

In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated.

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged over 55 will be screened for entry into the study.

After placebo run-in period, Patients will enter a 3 weeks double-blind treatment period.

Primary parameter is quality of sleep, secondary parameters are including getting to sleep, awakening from sleep, behavior following wakefulness, quality of day and night, sleep latency and quality of life.

Being tested
KI1001, Placebo KI1001
Keywords
primary insomnia
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.

  • KI1001Drug

    Prolonged release melatonin 2mg

  • Placebo KI1001Drug

    Placebo KI1001 tablets

Study groups in NCT01450228
Study groupRoleWhat they receive
Placebo KI1001Placebo comparatorNot described
Receives: Drug: Placebo KI1001
KI1001ExperimentalNot described
Receives: Drug: KI1001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QOS in LSEQ

    LSEQ - Leeds Sleep Evaluation Questionnaire QOS - Quality of Sleep

    Measured: three weeks

Secondary outcomes (7)

  1. GTS in LSEQ

    LSEQ - Leeds Sleep Evaluation Questionnaire GTS - Getting to Sleep

    Measured: three weeks

  2. QOD

    Quality of day in Patient Diary

    Measured: three weeks

  3. WHO 5-welling index

    Measured: three weeks

  4. PSQI

    Pittsburgh Sleep Quality Index

    Measured: three weeks

  5. AFS in LSEQ

    LSEQ - Leeds Sleep Evaluation Questionnaire AFS - Awakening from Sleep

    Measured: three weeks

  6. BFW in LSEQ

    LSEQ - Leeds Sleep Evaluation Questionnaire BFW - Behavior following Wakefulness

    Measured: three weeks

  7. QON

    Quality of Night in Patient Diary

    Measured: three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01450228
Sponsor's protocol ID
10-CC-8302
Status last verified
Apr 2012
First submitted
6 Oct 2011
Last updated
24 Apr 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KI1001 in people with Sleep Initiation and Maintenance Disorders, run by Kuhnil Pharmaceutical Co., Ltd. at 10 sites in South Korea.

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 29 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 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

QOS in LSEQ (time frame: three weeks). 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 NCT01450228.

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 24 Apr 2012.

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