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

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ClinicalTrials.gov Identifier: NCT02141230
Recruitment Status : Withdrawn
First Posted : May 19, 2014
Last Update Posted : June 30, 2016
Sponsor:
Collaborator:
Hamell
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Weight Loss Drug: Alli® 60 mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
Study Start Date : December 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
Experimental: Alli® 60 mg
Participants purchasing Alli®
Drug: Alli® 60 mg
Participants purchasing Alli®




Primary Outcome Measures :
  1. To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2. [ Time Frame: More than one year following introduction of updated labeling. ]
    BMI will be calculated from self-reported weight and height measures.

  2. To estimate the proportion of Alli® purchasers aged <18 years. [ Time Frame: More than one year following introduction of updated labeling. ]
    The survey will collect the demographic details including age.


Secondary Outcome Measures :
  1. To estimate the proportion of Alli® purchasers with contraindications to use (ciclosporin use, chronic malabsorption syndrome, cholestasis, pregnancy, breastfeeding, warfarin use). [ Time Frame: More than one year following introduction of updated labeling. ]
    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).

  2. 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). [ Time Frame: More than one year following introduction of updated labeling. ]
    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.

  3. 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. [ Time Frame: More than one year following introduction of updated labeling. ]
    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.

  4. For Alli® purchasers who have previously used OTC orlistat, descriptive data on the daily dose taken (number of capsules [or tablets]) will be collected. [ Time Frame: More than one year following introduction of updated labeling. ]
    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.

  5. To provide a descriptive comparison between the results of this survey and the previous surveys. [ Time Frame: More than one year following introduction of updated labeling. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141230


Sponsors and Collaborators
GlaxoSmithKline
Hamell
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02141230     History of Changes
Other Study ID Numbers: 202157
RH01159 ( Other Identifier: GSK )
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents