Sleep DisordersPhase 4NCT00530556
Insomnia and Daytime Function in Osteoarthritis
A Phase 4 study testing zolpidem in people with Sleep Disorders, run by Sanofi.
Trial summary
To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- zolpidem
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jun 2004
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are male or female aged 45 years or older.
- Patients having given their written informed consent prior to participating in the trial.
- Patients who have had OA of the knee or hip for at least 6 months, as diagnosed using the American College of Rheumatology Classification Criteria for Osteoarthritis.
- Patients who, based on historical data, developed insomnia together with or after development of arthritic symptoms and presently have difficulty in maintaining sleep or have non-restorative sleep for at least three months preceding study entry and have difficulties with daytime activities because of problems with sleeping.
- Patients who, based on historical data, experience sleep disturbance at least 3 nights per week.
- Patients must have a score of greater than 1 on the Likert Pain Scale within two weeks of study participation while taking pain medication
- Patients must have been on a stable dosing regimen of analgesic/anti-inflammatory medication for one month prior to study entry and agree to maintain the dose throughout the study. Patient must agree not to exceed 4000 mg (i.e., 1000 mg acetaminophen, 4 times per day) as rescue medication in case of unexpected arthritis pain. Acetaminophen is the only rescue medication allowed in addition to the patient's stable dosing regimen.
Who cannot join
- Female patients that are pregnant or are breast-feeding.
- Patients with reproductive potential not implementing adequate contraceptive measures.
- Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regimen.
- Patients that are shift workers or have required a change in their regular sleep schedule by at least three hours within the last three months.
- Patients that have been treated for insomnia within 2 years prior to the onset of osteoarthritis.
- Patients that have a history of recurrent major depressive disorder over the last 3 years or any single episode of major depression over the last 2 years.
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- Patients having a history of seizures or other significant neurological diseases.
- Patients with a history of myasthenia gravis.
- Patients that have had serious head injury within the past 10 years.
- Patients with insulin dependent diabetes poorly controlled in the opinion of the investigator.
- Patients who have had a stroke or myocardial infarction in the 6 months before the screening visit.
- Patients with unstable angina or severe heart failure.
- Patients with a history of significant impairment of any organ system that could impair the ability of the patient to participate in the study.
- Patients with abnormal clinical laboratory tests judged by the Investigator to require clinical intervention.
- Patients that fail to complete at least 3 of 7 consecutive nights and days (day must follow night to be consecutive) on their Evening and Morning Questionnaires during the screening period and have not satisfied the following:
- scored 2 or greater on the Evening Questionnaire, AND
- Slept a total of less than 6 hours, as determined by:
- a Wake Time after Sleep Onset of greater than 1 hour, and/or having time to fall asleep (sleep latency) of 45 minutes or greater.
- Patients that have used any drug (e.g. beta-blockers, antihistamines) and subsequently reported significant CNS side effects.
- Patients with a history of hypersensitivity/exaggerated drug response to sedative/hypnotic drugs (allergic or paradoxical), including zolpidem.
- Patients with a history of sleep apnea or current signs/symptoms associated with sleep apnea
- Patients with a history of symptoms compatible with diagnosis of periodic leg movement or restless legs syndrome.
- Patients with a history of cancer within the last 5 years or that have suspected neoplastic disease (with the exception of nonmelanomatous skin cancer).
- Patients that are taking any drugs of abuse or psychotropic drugs (including, but not limited to antidepressants, antipsychotics, or anxiolytics) or drugs with demonstrated effects on sleep-wake function (including, but not limited to herbal supplements, diphenhydramine, and theophylline).
- Patients that have used over-the-counter sleep medication within seven days prior to study entry. Prescription sleep medications must have been discontinued at least 7-25 days prior to study entry, depending upon the half-life of the particular compound.
- Patients who have taken investigational drugs within 30 days of the screening visit.
About this study
Official title: Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis
To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis
- Conditions
- Sleep Disorders
- Being tested
- zolpidem
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolpidemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Global Impression of Therapy of Insomnia
Secondary outcomes (1)
Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startMar 2003
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530556
- Sponsor's protocol ID
- L_8445
- Status last verified
- Feb 2012
- First submitted
- 14 Sep 2007
- Last updated
- 17 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00530556
- Acronym / sponsor ID
- L_8445
- Conditions
- Sleep Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 17 Sep 2007 (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.
To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients that are male or female aged 45 years or older.
- Patients having given their written informed consent prior to participating in the trial.
- Patients who have had OA of the knee or hip for at least 6 months, as diagnosed using the American College of Rheumatology Classification Criteria for Osteoarthritis.
- Patients who, based on historical data, developed insomnia together with or after development of arthritic symptoms and presently have difficulty in maintaining sleep or have non-restorative sleep for at least three months preceding study entry and have difficulties with daytime activities because of problems with sleeping.
- Patients who, based on historical data, experience sleep disturbance at least 3 nights per week.
Key exclusion criteria (26 listed)
- Female patients that are pregnant or are breast-feeding.
- Patients with reproductive potential not implementing adequate contraceptive measures.
- Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regimen.
- Patients that are shift workers or have required a change in their regular sleep schedule by at least three hours within the last three months.
- Patients that have been treated for insomnia within 2 years prior to the onset of osteoarthritis.
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 |
|---|---|---|
| zolpidem | Drug | – |
Primary outcome
Patient's Global Impression of Therapy of Insomnia
1 secondary outcome
Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications
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 Feb 2012.
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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.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zolpidem in people with Sleep Disorders, run by Sanofi.
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 7 inclusion and 26 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 Feb 2012. 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 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's Global Impression of Therapy of Insomnia. 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 Feb 2012; AzTrials last refreshed its copy on 29 Oct 2026.