Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 3:08 AM
Study NCT ID:
NCT01196650
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2010-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2011-05-02', 'studyFirstSubmitDate': '2010-09-05', 'studyFirstSubmitQcDate': '2010-09-05', 'lastUpdatePostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wake after sleep onset', 'description': 'To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo'}], 'secondaryOutcomes': [{'measure': 'Objective and Subjective sleep parameters', 'description': 'Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,'}]}, 'conditionsModule': {'conditions': ['Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between the ages of 18 and 65 years of age\n* Subjects that meet DSM IV diagnostic criteria for Insomnia\n* Subjects that report a time in bed NLT 6.5 and NMT 9 hours\n* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours\n* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep \\>1.0 hour\n* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset\n* On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes\n* On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes\n* On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights\n\nExclusion Criteria:\n\n* Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study\n* Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.\n* Subject with a history (past year) of alcohol or substance abuse\n* Subject that needs to smoke during the sleep period time\n* Subject that reports habitual napping (more than 3 times per week)'}, 'identificationModule': {'nctId': 'NCT01196650', 'briefTitle': 'Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intec Pharma Ltd.'}, 'officialTitle': 'A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep', 'orgStudyIdInfo': {'id': 'IN 10 003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'IN 10 003 formulation A', 'interventionNames': ['Drug: IN 10 003 formulation A']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'IN 10 003 formulation B', 'interventionNames': ['Drug: IN 10 003 formulation B']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo capsules', 'interventionNames': ['Drug: Placebo capsules']}], 'interventions': [{'name': 'IN 10 003 formulation A', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'IN 10 003 formulation B', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Placebo capsules', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intec Pharma Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hadas Friedman', 'oldOrganization': 'Intec Pharma Ltd.'}}}}