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Trial record 30 of 118 for:    ZOLPIDEM AND AIDS

A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

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.
ClinicalTrials.gov Identifier: NCT00466193
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : January 20, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Transcept Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 24, 2007
First Posted Date  ICMJE April 27, 2007
Results First Submitted Date  ICMJE December 15, 2011
Results First Posted Date  ICMJE January 20, 2012
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ]
    Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
  • Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ]
    Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00466193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ]
    Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
  • Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ]
    Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
  • Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. [ Time Frame: Weeks -1 to 0 ]
    Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
  • Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ]
    Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
  • Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ]
    The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
  • Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ]
    The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
  • Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ]
    Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.
  • Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ]
    Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
Brief Summary The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: zolpidem tartrate sublingual tablet
    3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
    Other Name: Intermezzo®
  • Drug: Placebo
    Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Study Arms  ICMJE
  • Experimental: Zolpidem 3.5mg
    Intervention: Drug: zolpidem tartrate sublingual tablet
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
295
Original Enrollment  ICMJE
 (submitted: April 24, 2007)
320
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with history of sleeplessness

Exclusion Criteria:

  • Allergic to investigational drug
  • Any conditions and medications that may interfere with study drug evaluation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00466193
Other Study ID Numbers  ICMJE ZI-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Transcept Pharmaceuticals
Study Sponsor  ICMJE Transcept Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Krystal, MD Clinical Neurophysiology Training Program, Duke University
Principal Investigator: Thomas Roth, PhD Sleep Disorders and Research Center, Henry Ford Hospital
PRS Account Transcept Pharmaceuticals
Verification Date February 2012

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