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Trial record 8 of 69 for:    ORLISTAT

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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE May 15, 2014
First Posted Date  ICMJE May 19, 2014
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02141230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
Official Title  ICMJE Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Weight Loss
Intervention  ICMJE Drug: Alli® 60 mg
Participants purchasing Alli®
Study Arms  ICMJE Experimental: Alli® 60 mg
Participants purchasing Alli®
Intervention: Drug: Alli® 60 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 29, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2014)
1524
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02141230
Other Study ID Numbers  ICMJE 202157
RH01159 ( Other Identifier: GSK )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Hamell
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP