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

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ClinicalTrials.gov Identifier: NCT00380081
Recruitment Status : Completed
First Posted : September 25, 2006
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 September 21, 2006
First Posted Date  ICMJE September 25, 2006
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 April 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ]
Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Sleep onset
Change History Complete list of historical versions of study NCT00380081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.
  • Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ]
    Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.
  • Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.
  • Subjective Sleep Quality Rating [ Time Frame: Days 1 and 2 for each treatment ]
    Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
  • Subjective Level of Refreshed Sleep [ Time Frame: Days 1 and 2 for each treatment ]
    Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
  • Subjective Ability to Function [ Time Frame: Days 1 and 2 for each treatment ]
    Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
  • Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.
  • Subjective Sleep Onset Latency After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.
  • Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.
  • Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.
  • Polysomnography Number of Awakenings After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]
    Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.
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, Crossover Study of the Efficacy and Safety of Sublingual Zolpidem Tartrate Tablet in Adult Patients With Insomnia Characterized by Difficulty Returning to Sleep After Middle-of-the-Night (MOTN) Awakening
Brief Summary The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet 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: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: zolpidem tartrate sublingual tablet 3.5mg
    Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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: zolpidem tartrate sublingual tablet 1.75mg
    Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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 administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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: placebo/zolpidem 3.5/zolpidem 1.75
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • Drug: Placebo
  • Experimental: placebo/zolpidem 1.75/zolpidem 3.5
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • Drug: Placebo
  • Experimental: zolpidem 3.5/placebo/zolpidem 1.75
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • Drug: Placebo
  • Experimental: zolpidem 3.5/zolpidem 1.75/placebo
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • Drug: Placebo
  • Experimental: zolpidem 1.75/placebo/zolpidem 3.5
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • Drug: Placebo
  • Experimental: zolpidem 1.75/zolpidem 3.5/placebo
    Interventions:
    • Drug: zolpidem tartrate sublingual tablet 3.5mg
    • Drug: zolpidem tartrate sublingual tablet 1.75mg
    • 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)
82
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insomnia as defined by DSM-IV criteria and supported by subject diary
  • Male or female between the ages of 18-64 years
  • Body mass index (BMI) between 18-34 kg/m^2
  • Females of childbearing potential must use a medically acceptable method of contraception
  • Capable of understanding and willing to comply with study procedures and has provided informed consent

Exclusion Criteria:

  • Females who are pregnant, breast-feeding or have a positive pregnancy test
  • Any circadian rhythm disorder including planned travel across several time zones during the study period
  • Known hypersensitivity to Zolpidem
  • Has performed regular shift work with the past several months prior to screening
  • An acute clinically significant illness or surgery as determined by the PI within 30 days of screening
  • Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle
  • A history of psychiatric disorder as defined by DSM-IV
  • A history of drug addiction or alcohol abuse
  • Any current significant disease, unless adequately controlled with a protocol allowed medication
  • Known history of HIV or Hepatitis B or C
  • Patients who have received an investigational drug within several months of screening
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380081
Other Study ID Numbers  ICMJE ZI-06-010
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: Thomas Roth, PhD Henry Ford Hospital, Sleep Disorders and Research Center
Principal Investigator: Martin Scharf, PhD Tri-State Sleep Disorders Center
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