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| ID | Type | Description | Link |
|---|---|---|---|
| RH01159 | Other Identifier | GSK |
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| Name | Class |
|---|---|
| Hamell | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alli® 60 mg | Experimental | Participants purchasing Alli® |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alli® 60 mg | Drug | Participants purchasing Alli® |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 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). | 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. |
| 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. |
| 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. |
| 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. |