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

Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196650
• Other study ID #: IN 10 003
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2010
• Last updated: May 2, 2011
• Start date: September 2010

Study information

• Verified date: September 2010
• Source: Intec Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Intervention

Drug:
• IN 10 003 formulation A

• IN 10 003 formulation B

• Placebo capsules

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rambam Medical Center	Haifa
Israel	Assuta Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Intec Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	Objective and Subjective sleep parameters	Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,		Yes