Last updated: 11/03/2018 22:42:35

Evaluating the effectiveness of the revised alli® pack information in helping pharmacy staff within the EU supply alli® appropriately.

GSK study ID
204675
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluating the effectiveness of the revised alli® pack information in helping pharmacy staff within the EU supply alli® appropriately.
Trial description: This observational study will evaluate whether revisions to the on-pack label for orlistat are effective in enabling pharmacy staff to make an appropriate decision to supply orlistat to consumers based upon the following criteria BMI (body mass index), age, contraindications and special warnings. The study will also identify whether there are specific criteria which pharmacy staff do not recognize as indications, contraindications or warnings for the use of orlistat.
Pharmacy staff will complete an online questionnaire containing a randomly ordered series of 33 virtual customers for whom they will
make yes/no decisions as to whether to supply orlistat and if no, they will be asked to provide the rationale for their decision.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proprtion of correct answer by pharmacy staff

Timeframe: 4 months

Secondary outcomes:

Proportion of correct responses for each sub-score i.e. indications, contraindications and warnings

Timeframe: 4 months

Proportion of false positives by the pharmacy staff

Timeframe: 4 months

Proportion of false negatives by the pharmacy staff

Timeframe: 4 months

Interventions:
  • Other: No intervention
    • Enrollment:
    480
    Primary completion date:
    2017-26-06
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Weight Loss
    Product
    orlistat
    Collaborators
    Not applicable
    Study date(s)
    December 2016 to June 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • Male or female
    • Qualified and practicing community pharmacist or pharmacy assistant in The UK or Spain
    • An employee of The Sponsor or The Research Company (Hamell)
    • Currently or previously (within last 6 months) employed by: A pharmaceutical company, healthcare company, market research company, healthcare advertising company, healthcare marketing company, regulatory or advisory authority.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female
    • Qualified and practicing community pharmacist or pharmacy assistant in The UK or Spain
    Exclusion criteria:
    • An employee of The Sponsor or The Research Company (Hamell)
    • Currently or previously (within last 6 months) employed by: A pharmaceutical company, healthcare company, market research company, healthcare advertising company, healthcare marketing company, regulatory or advisory authority.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Recruiting
    Actual primary completion date
    2017-26-06
    Actual study completion date
    2017-26-06

    Plain language summaries

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

    Additional information about the trial

    Additional information
    Not applicable
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