Last updated: 11/15/2018 22:20:14

A Dose-Ranging Study of a Tablet Formulation of Orlistatn/a

GSK study ID
W3730613
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 of a Tablet Formulation of Orlistat
Trial description: The aim of this study is to compare the activity of several orlistat tablet doses to 60mg orlistat capsules.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Fecal Fat Excretion

Timeframe: Up to 9 days post baseline

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Experimental dose 2
  • Drug: Experimental dose 4
  • Drug: Experimental dose 1
  • Drug: Experimental dose 3
  • Drug: Marketed formulation
  • Drug: Experimental dose 5
    • Enrollment:
    84
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Overweight
    Product
    orlistat
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to September 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 Year
    Accepts healthy volunteers
    none
    • Healthy, male or female, aged 18-60, Body Mass Index (BMI) of 25-33
    • Pregnant/breastfeeding, current history of gastro-intestinal (GI) disease or taking medications that affect normal GI function, clinically significant and relevant abnormalities of medical history or physical examination, orlistat use within one month prior to screening, current smoker, participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy, male or female, aged 18-60, Body Mass Index (BMI) of 25-33
    Exclusion criteria:
    • Pregnant/breastfeeding, current history of gastro-intestinal (GI) disease or taking medications that affect normal GI function, clinically significant and relevant abnormalities of medical history or physical examination, orlistat use within one month prior to screening, current smoker, participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

    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
    Not applicable
    Actual study completion date
    2009-09-09

    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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    Access to clinical trial data by researchers
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