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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

September 5, 2010
May 2, 2011
September 2010
Not Provided
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
Same as current
Complete list of historical versions of study NCT01196650 on ClinicalTrials.gov Archive Site
Objective and Subjective sleep parameters [ Designated as safety issue: Yes ]
Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
Same as current
Not Provided
Not Provided
 
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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
  • Active Comparator: 1
    IN 10 003 formulation A
    Intervention: Drug: IN 10 003 formulation A
  • Active Comparator: 2
    IN 10 003 formulation B
    Intervention: Drug: IN 10 003 formulation B
  • Placebo Comparator: 3
    Placebo capsules
    Intervention: Drug: Placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
Not Provided

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01196650
IN 10 003
Not Provided
Hadas Friedman, Intec Pharma Ltd.
Intec Pharma Ltd.
Not Provided
Not Provided
Intec Pharma Ltd.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP