Non-interventional study with Binosto 70 mg effervescent tablets once weekly investigating gastro-intestinal events and medication errors (Gastro-PASS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS10888
• Study ID:
  33495
• Official title and acronym:
  Non-interventional study with Binosto 70 mg effervescent tablets once weekly investigating gastro-intestinal events and medication errors (Gastro-PASS)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Spain
• Study description:
  Binosto® (effervescent alendronate) was developed with the aim of reducing the risk of oesophageal irritation, including the risk of tablet adhesion to the oesophageal wall. In addition, it was designed to provide a convenient dosage form that may improve treatment compliance among patients.; ; The safety profile of Binosto will be evaluated in a real-world clinical setting. This study will investigate upper gastrointestinal adverse events and medication errors associated with once-weekly administration of Binosto.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Actual:03/07/2014

Study start date

Planned:30/06/2017

Actual:24/05/2017

Date of final study report

Planned:31/07/2020

Actual:05/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

EffRx Pharmaceuticals SA

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)