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Trial record 41 of 121 for:    ZOLPIDEM AND Central Nervous System Depressants

Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

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: NCT00156533
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : May 16, 2013
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Wilfred Pigeon, PhD, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Insomnia
Primary Insomnia
Psychophysiologic Insomnia
Interventions Drug: Zolpidem
Drug: Sugar Pill
Enrollment 20
Recruitment Details Subjects recruited from television and newspaper ads. After a telephone or web based screening, subjects brought into the lab to read the Informed Consent Form (ICF). After the ICF has been signed, an initial medical and psychiatric evaluation completed. If the subjects remain eligible they are required to keep two weeks of sleep diaries.
Pre-assignment Details  
Arm/Group Title Placebo QHS (Nightly) Zolpidem Intermittant Zolpidem CTRL
Hide Arm/Group Description Once nightly dosing (quaque hora somni [QHS])with placebo Once nightly (QHS) dosing with 10mg of zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed Monitor only condition.
Period Title: Overall Study
Started 5 5 5 5
Completed 3 3 3 3
Not Completed 2 2 2 2
Reason Not Completed
Withdrawn - Medication Expiration             0             2             1             0
Withdrawal by Subject             1             0             0             1
Failed Screening             1             0             1             1
Arm/Group Title Placebo QHS Zolpidem Intermittant Zolpidem CTRL Total
Hide Arm/Group Description QHS dosing with placebo QHS dosing with 10mg of zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed Monitor only condition. Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 5 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
5
 100.0%
5
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 20 participants
Female
4
  80.0%
3
  60.0%
3
  60.0%
4
  80.0%
14
  70.0%
Male
1
  20.0%
2
  40.0%
2
  40.0%
1
  20.0%
6
  30.0%
1.Primary Outcome
Title Sleep Latency (SL)
Hide Description Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.
Time Frame Baseline and Post-treatment (12wks)
Hide Outcome Measure Data
Hide Analysis Population Description
Completers Only
Arm/Group Title Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Hide Arm/Group Description:
QHS (i.e., nightly) dosing with placebo
QHS (i.e., nightly) dosing with 10mg of zolpidem
Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
Monitor only condition (no placebo and no zolpidem).
Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
1 2 3 0
2.Secondary Outcome
Title Wake After Sleep Onset (WASO)
Hide Description Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.
Time Frame Baseline and Post-Treatment (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Completers
Arm/Group Title Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Hide Arm/Group Description:
QHS (i.e., nightly) dosing with placebo
QHS (i.e., nightly) dosing with 10mg of zolpidem
Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
Monitor only condition.
Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
1 2 2 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Hide Arm/Group Description QHS dosing with placebo QHS dosing with 10mg of zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed Monitor only condition.
All-Cause Mortality
Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo QHS Zolpidem Intermittant Zolpidem CTRL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
About 25% of the target sample was obtained. As a result our capacity to detect trends and to calculate effect sizes was greatly diminished. Accordingly, our observations must be very limited in scope.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Wilfred Pigeon
Organization: University of Rochester
Phone: 585 275-3374
Responsible Party: Wilfred Pigeon, PhD, University of Rochester
ClinicalTrials.gov Identifier: NCT00156533     History of Changes
Other Study ID Numbers: PI Initiated
11045 ( Other Identifier: University of Rochester )
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: October 10, 2011
Results First Posted: May 16, 2013
Last Update Posted: November 20, 2015