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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:
ClinicalTrials.gov Identifier:
NCT01196650
First Posted: September 8, 2010
Last Update Posted: May 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Intec Pharma Ltd.
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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

Resource links provided by NLM:


Further study details as provided by Intec Pharma Ltd.:

Primary Outcome Measures:
  • 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:
  • Objective and Subjective sleep parameters
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hadas Friedman, Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01196650     History of Changes
Other Study ID Numbers: IN 10 003
First Submitted: September 5, 2010
First Posted: September 8, 2010
Last Update Posted: May 3, 2011
Last Verified: September 2010

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