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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33495
• 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) has been developed with the aim of further reducing the risk of esophageal irritation, incl. the risk of tablet adhesion to the esophagus wall. In addition it is the aim to provide a convenient dosage form that would ensure better compliance across the patient population. The safety profile of Binosto will be evaluated in a real-life setting. The present study will investigate the upper gastrointestinal adverse events and medication errors associated with once weekly administration of Binosto.
• Study status:
  Planned

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

Date of final study report

Planned: 31/07/2020

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)