Clinical trial NCT02141230: Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
Official title: Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Hamell
First posted: 2014-05-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.

Exclusion Criteria:

* No exclusion criteria.

Primary outcomes:
measure: To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2.
timeFrame: More than one year following introduction of updated labeling.
measure: To estimate the proportion of Alli® purchasers aged <18 years.
timeFrame: More than one year following introduction of updated labeling.
Secondary outcomes:
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: 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.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: