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Insomnia and Daytime Function in Osteoarthritis

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. Read our disclaimer for details. Identifier: NCT00530556
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE September 14, 2007
First Posted Date  ICMJE September 17, 2007
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE March 2003
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Patient's Global Impression of Therapy of Insomnia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00530556 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Insomnia and Daytime Function in Osteoarthritis
Official Title  ICMJE Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sleep Disorders
Intervention  ICMJE Drug: zolpidem
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
Original Actual Enrollment  ICMJE
 (submitted: September 14, 2007)
Actual Study Completion Date  ICMJE June 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. scored 2 or greater on the Evening Questionnaire, AND
    2. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00530556
Other Study ID Numbers  ICMJE L_8445
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP