Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.

Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.

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.

Study Overview

• Status: Withdrawn
• Conditions: Weight Loss
• Intervention / Treatment: Drug: Alli® 60 mg

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alli® 60 mg; Participants purchasing Alli®	Drug: Alli® 60 mg; Participants purchasing Alli®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2.	BMI will be calculated from self-reported weight and height measures.	More than one year following introduction of updated labeling.
To estimate the proportion of Alli® purchasers aged <18 years.	The survey will collect the demographic details including age.	More than one year following introduction of updated labeling.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the proportion of Alli® purchasers with contraindications to use (ciclosporin use, chronic malabsorption syndrome, cholestasis, pregnancy, breastfeeding, warfarin use).	The survey will collect information on the history of contraindicated medical conditions (chronic malabsorption syndrome, cholestasis, pregnancy, breast-feeding) and use of contraindicated medications taken (ciclosporin, warfarin).	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).	Demographics characteristics of the customers who have bought Alli® (capsules or chewable tablets) for their own use and the information of their previous experience with Alli® will be recorded.	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.	History of kidney disease, or use of medication for hypothyroidism will be recorded in the survey for the customers who have previously used OTC orlistat.	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.	The survey will include the information on the the number of capsules (or tablets) taken per day for the customers who have previously used OTC orlistat.	More than one year following introduction of updated labeling.
To provide a descriptive comparison between the results of this survey and the previous surveys.	Based on the information collected in the survey, a descriptive comparison will be done between the results of this survey and the previous surveys to assess whether compliance with the authorized indication and contraindications among purchasers of Alli® has been improved.	More than one year following introduction of updated labeling.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Hamell

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): February 1, 2016
• Study Completion (ANTICIPATED): February 1, 2016

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (ESTIMATE): May 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 202157; RH01159 (OTHER: GSK)