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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02141230
• Other study ID #: 202157
• Secondary ID: RH01159
• Status: Withdrawn
• Phase: N/A
• First received: May 15, 2014
• Last updated: June 29, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Weight Loss

Intervention

Drug:
• Alli® 60 mg
Participants purchasing Alli®

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Hamell

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No