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

NCT02141230 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-06-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alli® 60 mg

Participants purchasing Alli®

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141230 on ClinicalTrials.gov