Last updated: 11/04/2018 13:05:57

A Dose-Ranging Study to Evaluate the Pharmacokinetics and Pharmacodynamics of a Sleep Aid

GSK study ID
V7341104
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Dose-Ranging Study to Evaluate the Pharmacokinetics and Pharmacodynamics of a Sleep Aid
Trial description: This initial dose-ranging Pharmacokinetic (PK) study is designed to identify the most appropriate doses of the test product to use to confirm efficacy in sleep induction.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

PK profiles and estimate parameters

Timeframe: change from baseline to 24 hours post dose

Secondary outcomes:

CDR testing of psychomotor function

Timeframe: change from baseline to 24 hours post dose

Karolinska Sleepiness Scale

Timeframe: change from baseline to 3 hours post dose

Interventions:
  • Drug: Doxylamine Succinate
    • Enrollment:
    24
    Primary completion date:
    2010-14-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Disorders
    Product
    doxylamine succinate
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to December 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 Year
    Accepts healthy volunteers
    none
    • Self-reported history of chronic intermittent difficulty with sleep at night, 2-5 nights a week, at least 1 week a month for the last 3 months.
    • Willingness to forego caffeine-containing products while confined to the study site (12 days).
    • Subjects with a history of glaucoma.
    • Subjects with a history of breathing problems, such as asthma, emphysema, or chronic bronchitis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Self-reported history of chronic intermittent difficulty with sleep at night, 2-5 nights a week, at least 1 week a month for the last 3 months.
    • Willingness to forego caffeine-containing products while confined to the study site (12 days).
    Exclusion criteria:
    • Subjects with a history of glaucoma.
    • Subjects with a history of breathing problems, such as asthma, emphysema, or chronic bronchitis.
    • Men who have a history of difficulty urinating due to an enlarged prostate gland.
    • Subjects who have a history of diabetes.
    • Subjects with reversed or shifting wake/sleep cycle.
    • Subject has donated blood or experienced significant blood loss within 56 days of Baseline visit, donated plasma within 7 days of Baseline visit, or has a hemoglobin value of <12.0 g/dl.
    • Subject has known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
    • Users of nicotine-containing products, including tobacco products and nicotine replacement therapies.
    • Has used any prescription medication within 30 days prior to dosing with the exception of lipid lowering drugs, antihypertensive medications, and oral contraceptives provided they have been stable on treatment for at least 1 month prior to study entry.
    • Has used any herbal or nutritional supplements (except vitamins and minerals) within 7 days prior to the first study session.
    • Has used any OTC medication, including herbal supplements, within 48 hours prior to the first study session.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-14-12
    Actual study completion date
    2010-14-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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