Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-10 @ 2:09 PM
Study NCT ID:
NCT00530556
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2007-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insomnia and Daytime Function in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-15', 'studyFirstSubmitDate': '2007-09-14', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Global Impression of Therapy of Insomnia"}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Insomnia,Sleep-related outcome measures from Morning Questionnaire, Daytime Functioning Life Event Questionnaire Pain Impact Questionnaire Use of rescue medications'}]}, 'conditionsModule': {'conditions': ['Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of zolpidem at doses up to 10 mg compared to placebo in patients with insomnia associated with osteoarthritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients that are male or female aged 45 years or older.\n* Patients having given their written informed consent prior to participating in the trial.\n* 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.\n* 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.\n* Patients who, based on historical data, experience sleep disturbance at least 3 nights per week.\n* Patients must have a score of greater than 1 on the Likert Pain Scale within two weeks of study participation while taking pain medication\n* 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.\n\nExclusion Criteria:\n\n* Female patients that are pregnant or are breast-feeding.\n* Patients with reproductive potential not implementing adequate contraceptive measures.\n* Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regimen.\n* 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.\n* Patients that have been treated for insomnia within 2 years prior to the onset of osteoarthritis.\n* 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.\n* Patients having a history of seizures or other significant neurological diseases.\n* Patients with a history of myasthenia gravis.\n* Patients that have had serious head injury within the past 10 years.\n* Patients with insulin dependent diabetes poorly controlled in the opinion of the investigator.\n* Patients who have had a stroke or myocardial infarction in the 6 months before the screening visit.\n* Patients with unstable angina or severe heart failure.\n* Patients with a history of significant impairment of any organ system that could impair the ability of the patient to participate in the study.\n* Patients with abnormal clinical laboratory tests judged by the Investigator to require clinical intervention.\n* 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:\n\n 1. scored 2 or greater on the Evening Questionnaire, AND\n 2. Slept a total of less than 6 hours, as determined by:\n\na Wake Time after Sleep Onset of greater than 1 hour, and/or having time to fall asleep (sleep latency) of 45 minutes or greater.\n\n* Patients that have used any drug (e.g. beta-blockers, antihistamines) and subsequently reported significant CNS side effects.\n* Patients with a history of hypersensitivity/exaggerated drug response to sedative/hypnotic drugs (allergic or paradoxical), including zolpidem.\n* Patients with a history of sleep apnea or current signs/symptoms associated with sleep apnea\n* Patients with a history of symptoms compatible with diagnosis of periodic leg movement or restless legs syndrome.\n* Patients with a history of cancer within the last 5 years or that have suspected neoplastic disease (with the exception of nonmelanomatous skin cancer).\n* 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).\n* 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.\n* Patients who have taken investigational drugs within 30 days of the screening visit."}, 'identificationModule': {'nctId': 'NCT00530556', 'briefTitle': 'Insomnia and Daytime Function in Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Effect of Zolpidem vs Placebo on Insomnia and Daytime Function in Patients With Insomnia Associated With Osteoarthritis', 'orgStudyIdInfo': {'id': 'L_8445'}}, 'armsInterventionsModule': {'interventions': [{'name': 'zolpidem', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}