Last updated: 11/03/2018 22:12:53

Risk Management Plan (RMP) survey for purchasers of Alli® (60 mg orlistat) in the European Union.

GSK study ID
202157
Clinicaltrials.gov ID
NCT02141230
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of the characteristics of Alli® purchasers in the European Union following the revision to the Alli® pack information.
Trial description: Following results from the first survey that forms part of the EU RMP for Alli® (RMP survey 1; WEUSRTP3350), several amendments to the information included on the pack carton for Alli® (orlistat 60 mg) were recommended. The main finding from RMP survey 1 was that a large proportion of Alli® users had a body mass index (BMI) less than (<)28 kg/m2 . (Note: the European indication for Alli® is adults 18 years and older with a BMI<28 kg/m2.) The proportion of respondents overall who reported possible contraindications to Alli® use was relatively low. The following changes to the pack labeling were agreed and have been implemented: : (1) a statement, highlighting the product is only for those with a BMI of 28 or above was added to the front of the pack; (2) wording of the BMI statement on the back of the pack was strengthened; (3) contraindications were highlighted in bold text; (4) the statement that Alli® is not for use by those under 18 years of age was modified for clarity. In addition, a pharmacy reminder card was made available to retail pharmacists to improve awareness of the prescribing information for Alli®. The survey will assess whether compliance with the authorized indication and contraindications among purchasers of Alli® has been improved after one year of marketing the revised pack labeling.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2.

Timeframe: More than one year following introduction of updated labeling.

To estimate the proportion of Alli® purchasers aged <18 years.

Timeframe: More than one year following introduction of updated labeling.

Secondary outcomes:

To estimate the proportion of Alli® purchasers with contraindications to use (ciclosporin use, chronic malabsorption syndrome, cholestasis, pregnancy, breastfeeding, warfarin use).

Timeframe: More than one year following introduction of updated labeling.

To characterise the demographic characteristics of Alli® purchasers in the EU and their patterns of previous use of over-the-counter (OTC) orlistat (defined as Alli® capsules or a generic equivalent, or alli chewable tablets).

Timeframe: More than one year following introduction of updated labeling.

To estimate the proportions of Alli® purchasers who have previously used OTC orlistat and who have a history of kidney disease or who are taking levothyroxine.

Timeframe: More than one year following introduction of updated labeling.

For Alli® purchasers who have previously used OTC orlistat, descriptive data on the daily dose taken (number of capsules [or tablets]) will be collected.

Timeframe: More than one year following introduction of updated labeling.

To provide a descriptive comparison between the results of this survey and the previous surveys.

Timeframe: More than one year following introduction of updated labeling.

Interventions:
  • Drug: Alli® 60 mg
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Weight Loss
    Product
    orlistat
    Collaborators
    Hamell
    Study date(s)
    December 2015 to February 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.
    • No exclusion criteria.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.
    Exclusion criteria:
    • No exclusion criteria.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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