- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196650
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
May 2, 2011 updated by: Intec Pharma Ltd.
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
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beer Sheva, Israel
- Soroka University Medical Center
-
Haifa, Israel
- Rambam Medical Center
-
Tel Aviv, Israel
- Assuta Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
IN 10 003 formulation A
|
|
Active Comparator: 2
IN 10 003 formulation B
|
|
Placebo Comparator: 3
Placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
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
Outcome Measure |
Measure Description |
---|---|
Objective and Subjective sleep parameters
|
Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Study Registration Dates
First Submitted
September 5, 2010
First Submitted That Met QC Criteria
September 5, 2010
First Posted (Estimate)
September 8, 2010
Study Record Updates
Last Update Posted (Estimate)
May 3, 2011
Last Update Submitted That Met QC Criteria
May 2, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IN 10 003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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