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
Ongoing
Ongoing
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
Observational study model:
Other
Primary completion date:
2017-26-06
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)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Ongoing
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

Not applicable
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