Weight LossNCT02141230
Risk Management Plan (RMP) Survey for Purchasers of Alli® (60 mg Orlistat) in the European Union.
A study testing Alli® 60 mg in people with Weight Loss, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weight Loss
- What is being tested?
- Alli® 60 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.
Who cannot join
- No exclusion criteria.
About this study
Official title: Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
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
- Weight Loss
- Being tested
- Alli® 60 mg
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alli® 60 mgDrug
Participants purchasing Alli®
| Study group | Role | What they receive |
|---|---|---|
| Alli® 60 mg | Experimental | Participants purchasing Alli® Receives: Drug: Alli® 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2.
BMI will be calculated from self-reported weight and height measures.
Measured: 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.
Measured: 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).
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: More than one year following introduction of updated labeling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startDec 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hamell
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141230
- Sponsor's protocol ID
- 202157
- Other IDs
- RH01159
- Status last verified
- Jun 2016
- First submitted
- 15 May 2014
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Characteristics of Alli® Purchasers in the European Union Following the Revision to the Alli® Pack Information.
- ClinicalTrials.gov ID
- NCT02141230
- Acronym / sponsor ID
- 202157
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Hamell
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alli® 60 mg | Experimental | Drug: Alli® 60 mgParticipants purchasing Alli® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any individual who purchases Alli from a pharmacy for their own personal use and provides consent.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alli® 60 mgParticipants purchasing Alli® | Drug | Alli® 60 mg |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A study testing Alli® 60 mg in people with Weight Loss, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the proportion of Alli® purchasers with a BMI <28 kg/m2. (time frame: More than one year following introduction of updated labeling.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.