Last updated: 03/24/2020 21:40:04

Study of the conditions of use and safety profile of alli (orlistat)

GSK study ID
212371
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: Etude des conditions d'utilisation et du profil de securite de'allli OR Study of the conditions of use and safety profile of Alli
Trial description: This observational study of consumers purchasing alli (registered trademark) in a retail pharmacy setting will evaluate the conditions of use and safety profile of alli
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of patients for whom alli is not indicated (e.g. because Body Mass Index less than 28, taking concomitant medications or co-morbid diseases indicated on the label)

Timeframe: 4 months

Secondary outcomes:

Adverse events

Timeframe: baseline to 4 months

Proportion of patients presenting with one or more special warnings or precautions indicated on the label

Timeframe: baseline to 4 months

Descriptive summary of characteristics of patients wishing to purchase alli

Timeframe: baseline

Descriptive summary of conditions of use

Timeframe: baseline to 4 months

Interventions:
  • Drug: orlistat
  • Other: No intervention
    • Enrollment:
    284
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Overweight
    Product
    orlistat
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to July 2010
    Type
    Observational
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Consumers who are interested in purchasing alli in a retail pharmacy setting.
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Consumers who are interested in purchasing alli in a retail pharmacy setting.
    Exclusion criteria:
    • None

    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
    2010-09-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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