Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

This study has been completed.

Sponsor:

Information provided by:

Intec Pharma Ltd.

ClinicalTrials.gov Identifier:

NCT01196650

First received: September 5, 2010

Last updated: May 2, 2011

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	September 5, 2010
Last Updated Date	May 2, 2011
Start Date ^ICMJE	September 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 5, 2010)	Wake after sleep onset [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01196650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 5, 2010)	Objective and Subjective sleep parameters [ Designated as safety issue: Yes ] Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Official Title ^ICMJE	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
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Intervention ^ICMJE	Drug: IN 10 003 formulation A Drug: IN 10 003 formulation B Drug: Placebo capsules
Study Arm (s)	Active Comparator: 1 IN 10 003 formulation A Intervention: Drug: IN 10 003 formulation A Active Comparator: 2 IN 10 003 formulation B Intervention: Drug: IN 10 003 formulation B Placebo Comparator: 3 Placebo capsules Intervention: Drug: Placebo capsules
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	24
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01196650
Other Study ID Numbers ^ICMJE	IN 10 003
Has Data Monitoring Committee	Not Provided
Responsible Party	Hadas Friedman, Intec Pharma Ltd.
Study Sponsor ^ICMJE	Intec Pharma Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Intec Pharma Ltd.
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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