Back to resultsComparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Primary Purpose
Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
IN 10 003 formulation A
IN 10 003 formulation B
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Eligibility Criteria
Inclusion Criteria:
- Subjects between the ages of 18 and 65 years of age
- Subjects that meet DSM IV diagnostic criteria for Insomnia
- Subjects that report a time in bed NLT 6.5 and NMT 9 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
- On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
- On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
- On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights
Exclusion Criteria:
- Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
- Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
- Subject with a history (past year) of alcohol or substance abuse
- Subject that needs to smoke during the sleep period time
- Subject that reports habitual napping (more than 3 times per week)
Sites / Locations
- Soroka University Medical Center
- Rambam Medical Center
- Assuta Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
IN 10 003 formulation A
IN 10 003 formulation B
Placebo capsules
Outcomes
Primary Outcome Measures
Wake after sleep onset
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
Secondary Outcome Measures
Objective and Subjective sleep parameters
Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01196650
Brief Title
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Intec Pharma Ltd.
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
IN 10 003 formulation A
Arm Title
2
Arm Type
Active Comparator
Arm Description
IN 10 003 formulation B
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
IN 10 003 formulation A
Intervention Type
Drug
Intervention Name(s)
IN 10 003 formulation B
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Objective and Subjective sleep parameters
Description
Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects between the ages of 18 and 65 years of age
Subjects that meet DSM IV diagnostic criteria for Insomnia
Subjects that report a time in bed NLT 6.5 and NMT 9 hours
Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights
Exclusion Criteria:
Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
Subject with a history (past year) of alcohol or substance abuse
Subject that needs to smoke during the sleep period time
Subject that reports habitual napping (more than 3 times per week)
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
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