Insomnia and Daytime Function in Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00530556
• Date of registration: 14/09/2007
• Primary sponsor: Sanofi-Aventis
• Public title: Insomnia and Daytime Function in Osteoarthritis
• Scientific title: Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis
• Date of first enrolment: March 2003
• Target sample size: 170
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00530556
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi-Aventis

Key inclusion & exclusion criteria

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.



Age minimum: 45 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sleep Disorders

Intervention(s)

Drug: zolpidem

Primary Outcome(s)

Patient's Global Impression of Therapy of Insomnia

Secondary Outcome(s)

Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications

Secondary ID(s)

L_8445

Source(s) of Monetary Support

Please refer to primary and secondary sponsors