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

Intec Pharma

Status and phase: Completed; Phase 2

Conditions: Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Treatments: Drug: Placebo capsules; Drug: IN 10 003 formulation A; Drug: IN 10 003 formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196650

IN 10 003

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

IN 10 003 formulation A

Treatment:

Drug: IN 10 003 formulation A

2

Active Comparator group

Description:

IN 10 003 formulation B

Treatment:

Drug: IN 10 003 formulation B

3

Placebo Comparator group

Description:

Placebo capsules

Treatment:

Drug: Placebo capsules