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Trial record 82 of 120 for:    ZOLPIDEM AND AIDS

Disturbed Sleep Model Study.

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: NCT00440323
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 23, 2007
First Posted Date  ICMJE February 27, 2007
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE January 5, 2007
Actual Primary Completion Date July 3, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
Total Sleep Time measured overnight across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2007)
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Change History Complete list of historical versions of study NCT00440323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2007)
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2007)
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disturbed Sleep Model Study.
Official Title  ICMJE A Double-blind, Double-dummy, Randomised, Placebo-controlled,Four-way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.
Brief Summary Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Condition  ICMJE Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • Drug: SB-649868
    SB-649868 tablets will be available with dose strength of 5 and 25 mg.
  • Drug: Zolpidem
    Zolpidem capsules will be available with dose strength of 10 mg.
    Other Name: SB-649868
  • Drug: Placebo
    Placebo tablet matching SB-649868 or Placebo capsule matching Zolpidem will be available.
Study Arms  ICMJE
  • Experimental: ADBC sequence
    In ADBC sequence A is Placebo, B is SB-649868 10 milligram (mg), C is SB-649868 30 mg, and D is Zolpidem 10 mg. Subject will receive placebo tablets, then two 5 mg tablets of SB-649868, then 25 mg and 5 mg tablet of SB-649868. There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: BACD sequence
    In BACD sequence subject will receive SB-649868 two tablets of 5 mg each (10 mg, B), Placebo tablets (A), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), and Zolpidem 10 mg (D). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: CBDA sequence
    In CBDA sequence subject will receive SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), SB-649868 two tablets of 5 mg each (10 mg, B), Zolpidem 10 mg (D) and Placebo tablet (A). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
  • Experimental: DCAB sequence
    In DCAB sequence subject will receive Zolpidem 10 mg (D), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), Placebo tablet (A), and SB-649868 two tablets of 5 mg each (10 mg, B). There will be wash-out period of 7 days.
    Interventions:
    • Drug: SB-649868
    • Drug: Zolpidem
    • Drug: Placebo
Publications * Bettica P, Squassante L, Groeger JA, Gennery B, Winsky-Sommerer R, Dijk DJ. Differential effects of a dual orexin receptor antagonist (SB-649868) and zolpidem on sleep initiation and consolidation, SWS, REM sleep, and EEG power spectra in a model of situational insomnia. Neuropsychopharmacology. 2012 Apr;37(5):1224-33. doi: 10.1038/npp.2011.310. Epub 2012 Jan 11.

*   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: February 26, 2007)
52
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 3, 2007
Actual Primary Completion Date July 3, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
  • Healthy as judged by responsible physician.
  • No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
  • The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

  • A positive result for the pre-study urine drug/ alcohol breath screen.
  • Abuse of alcohol.
  • Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00440323
Other Study ID Numbers  ICMJE OXS104094
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

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