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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
  Purpose

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


Condition Intervention Phase
Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
 Drug: IN 10 003 formulation A
Drug: IN 10 003 formulation B
Drug: Placebo capsules
 Phase 2

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

Further study details as provided by Intec Pharma Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Objective and Subjective sleep parameters [ Designated as safety issue: Yes ]
    Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,


Estimated Enrollment: 24
Study Start Date: September 2010
Arms Assigned Interventions
Active Comparator: 1
IN 10 003 formulation A
 Drug: IN 10 003 formulation A
Active Comparator: 2
IN 10 003 formulation B
 Drug: IN 10 003 formulation B
Placebo Comparator: 3
Placebo capsules
 Drug: Placebo capsules

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196650

Locations
Israel
Soroka University Medical Center
Beer Sheva, Israel
Rambam Medical Center
Haifa, Israel
Assuta Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Intec Pharma Ltd.
  More Information

No publications provided

Responsible Party: Hadas Friedman, Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01196650     History of Changes
Other Study ID Numbers: IN 10 003
Study First Received: September 5, 2010
Last Updated: May 2, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Stress, Psychological
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013