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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28353
• 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

GlaxoSmithKline (GSK)

Multiple centres: 250 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 22/12/2015

Actual: 22/12/2015

Study start date

Planned: 16/01/2017

Actual: 24/12/2016

Data analysis start date

Planned: 16/01/2017

Actual: 24/12/2016

Date of final study report

Planned: 19/03/2018

Actual: 19/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK Consumer Healthcare

Study protocol

Initial protocol

Redacted Protocol

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)