Last updated: 03/24/2020 21:40:04
Study of the conditions of use and safety profile of alli (orlistat)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Etude des conditions d'utilisation et du profil de securite de'allli OR Study of the conditions of use and safety profile of Alli
Trial description: This observational study of consumers purchasing alli (registered trademark) in a retail pharmacy setting will evaluate the conditions of use and safety profile of alli
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of patients for whom alli is not indicated (e.g. because Body Mass Index less than 28, taking concomitant medications or co-morbid diseases indicated on the label)
Timeframe: 4 months
Secondary outcomes:
Adverse events
Timeframe: baseline to 4 months
Proportion of patients presenting with one or more special warnings or precautions indicated on the label
Timeframe: baseline to 4 months
Descriptive summary of characteristics of patients wishing to purchase alli
Timeframe: baseline
Descriptive summary of conditions of use
Timeframe: baseline to 4 months
Interventions:
Drug: orlistat
Other: No intervention
Enrollment:
284
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Overweight
Product
orlistat
Collaborators
Not applicable
Study date(s)
April 2010 to July 2010
Type
Observational
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Consumers who are interested in purchasing alli in a retail pharmacy setting.
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Consumers who are interested in purchasing alli in a retail pharmacy setting.
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-09-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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