Insomnia and Daytime Function in Osteoarthritis

Sleep Disorders Clinical Trial

Official title:

Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530556
• Other study ID #: L_8445
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2007
• Last updated: February 15, 2012
• Start date: March 2003
• Est. completion date: June 2004

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• zolpidem

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Global Impression of Therapy of Insomnia
Secondary	Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications