InsomniaPhase 3NCT00095043
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
A Phase 3 study testing MK0928, gaboxadol in people with Insomnia, run by H. Lundbeck A/S.
Trial summary
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- MK0928, gaboxadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2006
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of Insomnia
Who cannot join
None listed.
About this study
Official title: A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.
Read the detailed description
The duration of treatment is 1 year.
- Conditions
- Insomnia
- Being tested
- MK0928, gaboxadol, Comparator: placebo
- 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.
MK0928, gaboxadolDrug
Comparator: placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after 12 months of treatment
Secondary outcomes (1)
Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2004 (estimated)
- Study startOct 2004
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095043
- Sponsor's protocol ID
- 0928-005
- Other IDs
- MK0928-005, 2004_088
- Status last verified
- Nov 2016
- First submitted
- 29 Oct 2004
- Last updated
- 17 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00095043
- Acronym / sponsor ID
- 0928-005
- Conditions
- Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2006 (actual)
- First posted
- 1 Nov 2004 (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.
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.
Detailed description
The duration of treatment is 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Insomnia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MK0928, gaboxadol | Drug | – |
| Comparator: placebo | Drug | – |
Primary outcome
Safety and tolerability after 12 months of treatment
1 secondary outcome
Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
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 17 Nov 2016.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0928, gaboxadol in people with Insomnia, run by H. Lundbeck A/S.
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 1 inclusion and 0 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Safety and tolerability after 12 months of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2016.