Study identification

EU PAS number

EUPAS15840

Study ID

28353

Official title and acronym

Evaluating the effectiveness of the revised alli® pack information in helping pharmacy staff within the EU supply alli® appropriately (204675)

DARWIN EU® study

No

Study countries

Spain
United Kingdom

Study description

Following the results of the two EU Risk Management Plan (RMP) surveys, several amendments to the information on the pack carton for alli® in the EU were recommended. The purpose of this survey, is to assess whether amendments to the pack text and format have been effective in ensuring appropriate recommendation of the product by pharmacy staff.Study Objectives are: 1. To evaluate whether revisions to the on-pack label changes for alli® are effective in enabling pharmacy staff make an appropriate decision to supply alli® to consumers based on the following criteria:•BMI (≥28 kg/m2)•Age (≥18 years old)•Contraindications to use of alli® (taking ciclosporin, chronic malabsorption syndrome, cholestasis, pregnancy or breast-feeding, taking warfarin or other oral anticoagulant)•Special warnings to use of alli® (kidney disease, taking levothyroxine, amiodarone, antidiabetics, antiretrovirals, antidepressants, antipsychotics, benzodiazepines or cholesterol lowering drugs): Consumer must have consulted their doctor prior to Use2. To identify whether there are specific criteria which pharmacy staff do not recognise as indications, contraindications or warnings for the use of alli®

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 250 centres are involved in the study

Contact details

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor Cdr_mailbox@gsk.com

Study contact
Cdr_mailbox@gsk.com

GSK Clinical Disclosure Advisor GSK Clinical Disclosure Advisor

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GSK Consumer Healthcare
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)