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

Phase 2

Completed

• Conditions: Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
• Interventions: Drug: IN 10 003 formulation A; Drug: IN 10 003 formulation B; Drug: Placebo capsules

• Registration Number: NCT01196650
• Lead Sponsor: Intec Pharma Ltd.

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 available

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-05
• Study First Submitted QC: 2010-09-05
• Study First Posted: 2010-09-08
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	IN 10 003 formulation A	IN 10 003 formulation A
2	IN 10 003 formulation B	IN 10 003 formulation B
3	Placebo capsules	Placebo capsules

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Objective and Subjective sleep parameters		Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,

Trial Locations

Locations (3)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel