NCT02141230

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

May 15, 2014

Last Update Submit

June 29, 2016

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

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

    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).

    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.

    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.

    More than one year following introduction of updated labeling.

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

    More than one year following introduction of updated labeling.

Study Arms (1)

Alli® 60 mg

EXPERIMENTAL

Participants purchasing Alli®

Drug: Alli® 60 mg

Interventions

Alli® 60 mgDRUG

Participants purchasing Alli®

Alli® 60 mg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Loss

Interventions

Orlistat

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 30, 2016

Record last verified: 2016-06